HEMASHIELD GOLD KNITTED

Additional Manufacturer Narrative

(10/4248/213) FURTHER RESULTS FROM THE CONDUCTED INVESTIGATION CONCLUDED THAT THE HOLE INITIALLY DESCRIBED BY THE SURGEON HAS NOT BEEN OBSERVED, ONLY THE HOLES THROUGH WHICH THE LIGATURE THREAD PASSED WERE VISIBLE. IN ADDITION, IT WAS NOTICED THAT A MATERIAL, PROBABLY THE COLLAGEN LAYER WAS CRUMBLING ALL OVER THE INSERTION AREA. IT COULD BE CAUSED BY IMPROPER THE STORAGE CONDITION BY THE CUSTOMER, WITHOUT FORMALIN SOLUTION. (67/61) BASED ON THE INVESTIGATION FINDINGS, NO CONCLUSION CAN BE DRAWN ON THE EXACT ORIGIN OF REPORTED INCIDENT. THE RESULTS REVEALED THAT THE PRODUCT WAS HANDLED BY THE CUSTOMER AND THE PRESENCE OF A LIGATURE WAS OBSERVED. ONLY THE HOLES CAUSED BY THE LIGATURE THREAD WERE OBSERVED ON THE PRODUCT, AND NO OTHER HOLES RELATED TO THE REPORTED INCIDENT WERE NOTICED. ON THIS BASIS, THE CUSTOMER'S OBSERVATION IS NOT CONFIRMED. HOWEVER, THE CONDUCTED INVESTIGATION AND TESTING PERFORMED SUGGEST THAT THE PRODUCT WAS NOT DEFECTIVE AT THE TIME OF MANUFACTURING.

Description of Event or Problem

COMPLAINT #(B)(4).

Additional Manufacturer Narrative

(4111/4248) ADDITIONAL INFORMATION WAS REQUESTED TO THE INITIAL REPORTER SINCE THE APPEARANCE OF THE RETURNED PRODUCT DOES NOT CORRESPOND TO THE INITIAL DESCRIPTION. INDEED, THE PRODUCT HAD BEEN HANDLED BY THE CUSTOMER UNLIKE AS INITIALLY DESCRIBED. - THE COMPANY REPRESENTATIVE CAME BACK TO INITIAL REPORTER ASKING WHETHER THE GRAFT WAS PRESOAKED AND SHE WAS NOT SURE. HER INFO WAS THAT IT WAS OPENED TO THE FIELD, HOLE WAS FOUND, NOT USED AND NEVER MADE IT TO THE PATIENT. ASSUMPTION IS BLOODY GLOVES HANDLED THE GRAFT. SHE SAID WHEN SHE ORIGINALLY RECEIVED THE GRAFT IN HER OFFICE, THE GRAFT WAS MUCH WHITER. - MOREOVER, THE COMPANY REPRESENTATIVE MET WITH THE CLINICIAN ABOUT THE GRAFT ISSUE. HE SAID THAT IT WAS A HECTIC AORTIC DISSECTION CASE WITH NO FURTHER DETAILS OR ANSWERS TO PROVIDE. THE PRODUCT DID NOT MAKE IT INTO THE PATIENT AS THE HOLE WAS NOTED EARLY. THE COMPANY REPRESENTATIVE RE-ADDRESSED THAT WOVEN GRAFTS MANUFACTURED BY INTERVASCULAR DO NOT REQUIRE PRESOAK. (10/3233) THE INVOLVED DEVICE WAS SENT TO AN EXTERNAL AND INDEPENDENT LABORATORY FOR EXAMINATION. THE PRELIMINARY RESULTS OF THE MACROSCOPIC ANALYSIS REVEALED THE PRESENCE OF A SMALL PART OF THE PROSTHESIS THAT HAS BEEN INSERTED INSIDE THE MAIN PART AND FIXED WITH A LIGATURE. THE HOLE INITIALLY DESCRIBED HAS NOT BEEN OBSERVED. FURTHER INVESTIGATION IS BEING CONDUCTED, RESULTS ARE PENDING. (11) THE INVESTIGATION IS STILL ONGOING. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

COMPLAINT # (B)(4).

Additional Manufacturer Narrative

(4109/213) THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER 19F19. (3331/213) THE DEVICE HISTORY RECORDS REVIEW CONCLUDED THAT THERE WAS NO NON CONFORMANCE/PLANNED DEVIATION IN RELATION WITH THE EVENT REPORTED. (10/3233) THE INVOLVED DEVICE WAS SENT TO AN EXTERNAL AND INDEPENDENT LABORATORY FOR EXAMINATION. THE INVESTIGATION IS ONGOING. (4111/3233) MORE INFORMATION HAS BEEN REQUESTED TO THE INITIAL REPORTER, RESPONSES ARE PENDING. (11) THE INVESTIGATION IS STILL ONGOING. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION. H3 OTHER TEXT : 10- TESTING OF INVOLVED DEVICE IS ONGOING.

Description of Event or Problem

IT WAS REPORTED TO INTERVASCULAR THAT WHEN THE CUSTOMER OPENED CATALOG KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT (M002020955070), A HOLE IN THE GRAFT WAS NOTICED STRAIGHT OUT OF THE PACKAGE. THE SURGERY WAS NOT DELAYED SINCE A BACKUP GRAFT WAS AVAILABLE TO COMPLETE THE OPERATION. ADDITIONAL INFORMATION RECEIVED FROM INITIAL REPORTER INDICATES THAT THE INVOLVED PRODUCT DID NOT MAKE IT INTO THE PATIENT. NO CONSEQUENCE FOR THE PATIENT WAS REPORTED AND THE PRODUCT WAS RETURNED FOR INVESTIGATION.