UNK - ZIPFIX IMPLANTS

Additional Manufacturer Narrative

DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: H3, H6: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE ARTICLE HAS BEEN REVIEWED: GIUSEPPE T, ANAMUL I, AMBER M, DANIEL L B. PREDOMINANT USE OF BILATERAL INTERNAL MAMMARY ARTERIES IN OFF-PUMP CORONARY ARTERY BYPASS SURGERY. WWW.AJCONLINE.ORG. HTTPS://DOI.ORG/10.1016/J.AMJCARD.2024.06.004 OBJECTIVE/METHODS/STUDY DATA: THIS SINGLE-CENTER RETROSPECTIVE STUDY AIMS TO SYSTEMATICALLY COMPARED THE EARLY (30-DAY) POSTOPERATIVE OUTCOMES BETWEEN THE BIMA AND SIMA COHORTS IN MATCHED PATIENTS. BETWEEN NOVEMBER 202 AND JULY 2023, A TOTAL OF 546 PATIENTS WHO UNDERWENT ISOLATED OFF-PUMP CORONARY ARTERY BYPASS GRAFT CATEGORIZED WITH BILATERAL INTERNAL MAMMARY ARTERY (BIMA) TREATMENT CONSISTED OF 300 PATIENTS WITH A MEAN AGE OF 64+/-10 AND SINGLE INTERNAL MAMMARY ARTERY TREATMENT CONSISTED OF 216 WITH A MEAN AGE OF 65+/-12. THESE PATIENTS WERE TREATED WITH THE STERNAL ZIPFIX SYSTEM (DEPUY SYNTHES, WEST CHESTER, USA). FOLLOW-UP WERE UNKNOWN. FOLLOW-UP WERE UNKNOWN. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SYNTHES ZIPFIX SYSTEM ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - ZIPFIX IMPLANTS (QTY 36) -12 PATIENTS HAD SUPERFICIAL STERNAL INFECTION. 8 OF THESE PATIENTS WERE READMITTED. -1 PATIENT HAD DEEP STERNAL INFECTION. THIS PATIENT WAS READMITTED. -1 PATIENT HAD SAPHENOUS VEIN GRAFTS SITE INFECTION. THIS PATIENT WAS READMITTED. -5 PATIENTS HAD SEPSIS. NO INTERVENTION PROVIDED. -17 PATIENTS HAD PNEUMONIA. NO INTERVENTION PROVIDED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # :(B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H11: ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE.