DYNAMIC Y STENT
Received Apr 12, 2016 · Event occurred Mar 15, 2016
Report 3005099803-2016-00962 · MDR key 5569342
Device
Generic name
Prosthesis, Tracheal, Expandable, Polymeric
Manufacturer
Willy Ruesch GmbhModel number
M00570670Lot number
0000014151
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem
NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED WITHIN THE SAME PATIENT. REFER TO MANUFACTURER REPORT # 3005099803-2016-00963 AND 3005099803-2016-00962 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2016, THAT TWO DYNAMIC Y STENTS WERE TO BE USED TO TREAT A STRICTURE IN THE APEX OF THE MAIN CARINA AND TRACHEA DURING A PROCEDURE PERFORMED ON (B)(6) 2016. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE USER HAD DIFFICULTY POSITIONING/PLACING THE FIRST DYNAMIC Y STENT (THE SUBJECT OF MFR. REPORT# 3005099803-2016-00963). REPORTEDLY, THE STENT WAS TOO STIFF AND DID NOT CONFORM COMFORTABLY TO THE PATIENT. THE DYNAMIC Y STENT WAS REMOVED FROM THE PATIENT AND A SECOND DYNAMIC Y STENT (THE SUBJECT OF MFR. REPORT# 3005099803-2016-00962) WAS USED; HOWEVER, THE SAME ISSUE OCCURRED AND THE STENT WAS REMOVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. ATTEMPTS TO OBTAIN ADDITIONAL PROCEDURE INFORMATION HAVE BEEN UNSUCCESSFUL. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.