INDY OTW VASCULAR RETRIEVER

Additional Manufacturer Narrative

THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

Description of Event or Problem

IT WAS REPORTED AN INDY OTW VASCULAR RETRIEVER SEPARATED DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. THE DEVICE WAS INTENDED TO BE USED TO CATCH A WIRE GUIDE DURING THE PROCEDURE. WHEN THE ILIAC LEG GRAFT WAS PLACED, THE SNARE CAUGHT ON THE SUPRARENAL STENT OF THE ILIAC LEG GRAFT AND THE SNARE COULD NOT BE REMOVED. THE USER PULLED ON THE SNARE DEVICE FORCEFULLY AND THE DEVICE SEPARATED AT THE JOINT OF THE CATHETER AND SNARE WIRE. THE CATHETER AND SNARE WIRE COMPONENT REMAINS INSIDE THE PATIENT NEAR THE CELIAC ARTERY IN THE AORTA. THE EVAR PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE IS NO PLANNED ADDITIONAL PROCEDURE TO RETRIEVE THE SEPARATION PORTION OF THE DEVICE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

Additional Manufacturer Narrative

INVESTIGATION ¿ EVALUATION: OSAKA UNIVERSITY HOSPITAL INFORMED COOK ON 02MAY2022 OF AN EVENT INVOLVING INDY OTW VASCULAR RETRIEVER RPN: INDY-8.0-35-100-40 (PRODUCT LOT 13340675). ON 28APR2022, THE PATIENT UNDERWENT A EVAR PROCEDURE. DURING THE PROCEDURE THE INDY DEVICE WAS INSERTED TO CATCH A WIRE GUIDE, THE LOOP OF THE INDY WIRE SNARE GOT CAUGHT ON THE SUPRARENAL STENT OF THE PREVIOUSLY IMPLANTED STENT GRAFT AND COULD NOT BE REMOVED WHEN AN ILIAC LEG GRAFT WAS PLACED. THE PHYSICIAN PULLED FORCEFULLY ON THE INDY SNARE AND THEN IT BROKE. THIS MADE THE SNARE CATHETER WITH THE SNARE WIRE ATTACHED REMAIN NEAR THE CELIAC ARTERY IN THE AORTA. THE PROCEDURE WAS COMPLETED WITH THE SEGMENTS OF THE INDY SNARE REMAINING IN THE PATIENT. THE PATIENT HAD A PREVIOUS HISTORY OF ABDOMINAL AORTA REPLACEMENT WITH AN ARTIFICIAL VESSEL, AS WELL AS STENT GRAFT PLACEMENT IN THE ABDOMINAL AND THORACIC AORTA. IT WAS REPORTED THE PHYSICIAN WAS USING THE INDY SNARE TO CATCH A WIRE GUIDE. THE PHYSICIAN HAS NO PLANS TO RETRIEVE THE SEGMENTS OF THE SNARE THAT REMAIN IN THE PATIENT. REVIEWS OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DRAWING, DEVICE HISTORY RECORD (DHR), QUALITY CONTROL, SPECIFICATIONS, MANUFACTURING INSTRUCTIONS (MI), AND INSTRUCTIONS FOR USE (IFU) WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DHRS FOR THE REPORTED COMPLAINT DEVICE LOT REVEALED TWO NON-CONFORMANCES; HOWEVER, THESE DEVICES WERE REWORKED AND RE-INSPECTED PRIOR TO FURTHER PROCESSING. A DATABASE SEARCH DID NOT IDENTIFY ANY OTHER EVENTS ASSOCIATED WITH THE REPORTED DEVICE LOT. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION AND THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE DEVICE WAS PACKAGED WITH IFU T_INDYOTW_REV5. THE IFU INCLUDES THE FOLLOWING, WARNINGS, PRECAUTIONS, AND INSTRUCTIONS FOR PROPER PLACEMENT OF THE DEVICE: ¿PRECAUTIONS ¿ MANIPULATION OF THE PRODUCT REQUIRES FLUOROSCOPIC CONTROL. ¿ VISUALLY INSPECT THE PRODUCT BEFORE USE TO ENSURE IT IS UNDAMAGED. INSTRUCTIONS FOR USE 4.INSERT THE RETRIEVER OVER-THE-WIRE THROUGH AN IN SITU GUIDING CATHETER OR INTRODUCER SHEATH AND ADVANCE IT TO THE DESIRED POSITION. 5.WHILE HOLDING THE FLEXOR SHEATH IN POSITION, LOOSEN TUOHY-BORST AND ADVANCE THE INNER CATHETER THROUGH THE FLEXOR SHEATH UNTIL THE SNARE EMERGES FROM THE DISTAL TIP. NOTE: THE SNARE WILL EXPAND UPON EMERGENCE FROM THE FLEXOR SHEATH. 6.POSITION THE RETRIEVER SO THAT THE FOREIGN BODY, SUCH AS A WIRE GUIDE OR CATHETER, IS CAUGHT WITHIN THE SNARE. WHILE MAINTAINING THE SNARE POSITION, SLIDE THE FLEXOR SHEATH FORWARD TO CAPTURE THE FOREIGN BODY. 7.TIGHTEN TUOHY-BORST TO MAINTAIN TENSION ON THE CATHETER CONTROLLING THE FOREIGN BODY, WITHDRAW THE RETRIEVER, INCLUDING THE SNARE AND FLEXOR SHEATH ASSEMBLY, TO A PERIPHERAL LOCATION AND RETRIEVE THE FOREIGN BODY.¿ AFTER REVIEW OF THE IFU, COOK HAS CONCLUDED THE DEVICE LABELING CONTAINS APPROPRIATE WARNINGS, PRECAUTIONS AND INSTRUCTIONS TO THE USER RELATED TO THE REPORTED FAILURE. BASED ON THE AVAILABLE INFORMATION, NO DEVICE RETURN, AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE CAUSE FOR THE REPORTED FAILURE COULD NOT BE ESTABLISHED FOR THIS EVENT. A POSSIBLE CAUSE THAT LIKELY CONTRIBUTED TO THE SEPARATION OF THE DEVICE IS EXCESSIVE FORCE APPLIED DURING THE PROCEDURE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

Description of Event or Problem

NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.