HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR VASCULAR GRAFT

Description of Event or Problem

SEE INITIAL MFG REPORT NUMBER: 1640201-2021-00025. COMPLAINT # (B)(4).

Additional Manufacturer Narrative

(10/170) THE INVOLVED DEVICE WAS SENT TO AN EXTERNAL AND INDEPENDENT LABORATORY FOR EXAMINATION. IN SUMMARY, THE CONCLUSIONS OF THE REPORT ARE AS FOLLOWS: "THE MACROSCOPIC ANALYSIS OF THE [RETURNED DEVICE] REVEALS SOME IRREGULARITIES ON THE SURFACE OF THE GRAFT WITH LIGHT-YELLOW MASSES AND MARKS. THE MICROSCOPICAL ASPECT OF THESE IRREGULARITIES SUGGESTS THAT THEY CORRESPOND TO COLLAGEN TRACES AND BALLS ON THE COATING OF THE PROSTHESIS." AFTER REVIEWING THE LABORATORY ANALYSIS REPORT, THE QA MANAGER ASSESSED THAT THE DEFICIENCY REPORTED IS IDENTIFIED AS AN EXCESS OF COLLAGEN ON THE EXTERNAL PART OF THE GRAFT. THERE IS NO PATIENT RISK, IT IS A COSMETIC DEFECT. (25) THE OUTCOME OF OUR INVESTIGATION, WHICH INCLUDED ALL AVAILABLE INFORMATION AND THE TESTING WE PERFORMED, SUGGESTS THAT THE RETURNED GRAFT WAS DEFECTIVE. THE ISSUE IS RELATED TO A COLLAGEN EXCESS DEFECT. A NON-CONFORMITY REPORT HAS BEEN INITIATED IN ORDER TO INVESTIGATE THE CAUSE AND TAKE APPROPRIATE CORRECTIVE ACTIONS IF NECESSARY. IT HAS BEEN DECIDED TO RAISE AWARENESS OF THIS TYPE OF DEFECT AMONG THE CONCERNED MANUFACTURING OPERATORS. PLEASE NOTE THAT THIS DEFECT IS ONLY COSMETIC AND HAS NO IMPACT ON THE PATIENT.

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORDS REVIEW DID NOT FIND ANY DISCREPANCY IN RELATION WITH THE EVENT REPORTED. THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER 20J09. ONE RETENTION SAMPLE WAS SELECTED BASED ON THE CLOSEST CHARACTERISTICS OF THE COMPLAINT PRODUCT: STERILIZATION LOT, TYPE OF PRODUCT (WOVEN/STRAIGHT), DATE OF COATING AND DATE OF PRIMARY PACKAGING. THE GOAL WAS TO FIND A PRODUCT THAT HAS UNDERGONE THE SAME TYPE OF MANUFACTURING STEPS DURING A CLOSE PERIOD. PRODUCT M00202175126P0, SN(B)(4), LOT 20J16, WAS CHOSEN AS THE MOST REPRESENTATIVE. A VISUAL INSPECTION HAS BEEN PERFORMED BY THE QA MANAGER ON THIS RETENTION SAMPLE. THE CONCLUSION IS AS FOLLOWS : "I HAVE ANALYZED THE PRODUCT RETENTION. THE PRODUCT IS IN COMPLIANCE WITH OUR SPECIFICATION. THERE MAY BE SLIGHT VARIATIONS IN COLOR DUE TO THE COLLAGEN PRESENT ON THE PROSTHESIS." THE PRODUCT IS AVAILABLE AND WILL BE RETURNED FOR EXAMINATION THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

UPON OPENING THE GRAFT PACKAGE, SURGEON NOTED THAT THERE WERE SPOTS OF DISCOLORATION ON THE GRAFT MATERIAL (BROWN SPOTS ON THE CREAM COLORED GRAFT). SURGEON DID NOT KNOW IF THESE SPOTS WERE AN INDICATION OF A DEFECT, BUT HAD NOT ENCOUNTERED SUCH SPOTS IN HIS PREVIOUS USES OF HEMASHIELD PLATINUM GRAFTS AND THEREFORE ELECTED NOT TO IMPLANT THIS GRAFT. AN IDENTICAL GRAFT WAS SELECTED AND IMPLANTED SUCCESSFULLY. THERE WAS NO IMPACT ON THE PATIENT HEALTH STATUS. THE PREVIOUS GRAFT WAS NEVER IN CONTACT WITH THE PATIENT. WE LEARNED LATER THAT THE GRAFT WAS OPENED AND HANDLED BY THE SURGEON IN THE STERILE FIELD ON THE DATE OF THE PROCEDURE. WHILE THE GRAFT WAS NOT ULTIMATELY IMPLANTED, THE SURGEON WOULD HAVE HAD BLOOD ON HIS GLOVES WHICH TRANSFERRED TO THE GRAFT. AS A RESULT , THE INVOLVED GRAFT WILL NEED TO BE SHIPPED AS A BIOHAZARD. COMPLAINT # (B)(4).