UNK - ZIPFIX IMPLANTS

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.

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 LINCOLN B. BILATERAL INTERNAL MAMMARY ARTERY IN OFF-PUMP CORONARY ARTERY GRAFTING IN DIABETIC PATIENTS. JOURNAL HOMEPAGE: WWW.ELSEVIER.COM/LOCATE/AJC. HTTPS://DOI.ORG/10.1016/J.AMJCARD.2025.01.030. OBJECTIVE/METHODS/STUDY DATA: THIS SINGLE-CENTER RETROSPECTIVE STUDY COMPARES OUTCOMES OF DIABETIC PATIENTS UNDERGOING BIMA VERSUS SIMA GRAFTING WITH ISOLATED OPCAB, SPECIFICALLY FOCUSING ON POSTOPERATIVE OUTCOMES SUCH AS MORTALITY, WOUND INFECTIONS, AND OTHER COMPLICATIONS, TO ASSESS WHETHER BIMA GRAFTING CAN BE SAFELY USED IN DIABETIC PATIENTS. BETWEEN JANUARY 2020 AND DECEMBER 2023, A TOTAL OF 412 PATIENTS WHO UNDERWENT ISOLATED OFF-PUMP CORONARY ARTERY BYPASS GRAFT CATEGORIZED WITH BILATERAL INTERNAL MAMMARY ARTERY (BIMA) TREATMENT CONSISTED OF 207 PATIENTS WITH A MEAN AGE OF 63+/-9 AND SINGLE INTERNAL MAMMARY ARTERY TREATMENT CONSISTED OF 205 PATIENTS WITH A MEAN AGE OF 66+/-11. THESE PATIENTS WERE TREATED WITH THE STERNAL ZIPFIX SYSTEM (DEPUY SYNTHES, WEST CHESTER, USA). 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 42). 7 PATIENTS HAD SUPERFICIAL STERNAL INFECTION. 6 OF THEM WERE READMITTED. 4 PATIENTS HAD DEEP STERNAL INFECTION. ALL OF THEM WERE READMITTED. 1 CASE OF HARVEST SAPHENOUS VEIN GRAFT SITE INFECTION. THIS PATIENT WAS READMITTED. 7 PATIENTS HAD SEPSIS. NO INTERVENTION PROVIDED. 23 PATIENTS HAD PNEUMONIA. NO INTERVENTION PROVIDED.