STLESS STEEL SIL 4X18IN 5 S/A V-40

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 5/21/2025. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL INFORMATION: H6. THE FOLLOWING INFORMATION WAS RECEIVED: AFTER THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED DURING SURGERY, THE SURGEON IMMEDIATELY REPLACED A NEW SUTURE (WITH SPECIFIC PRODUCT INFORMATION UNKNOWN) TO CONTINUE THE SUTURING. THE SUBSEQUENT SURGICAL SUTURING WENT SMOOTHLY. THIS EVENT LED TO PROLONGED OPERATION TIME (SPECIFIC PROLONGATION TIME UNKNOWN) AND INCREASED INTRAOPERATIVE BLOOD LOSS (SPECIFIC BLOOD LOSS UNKNOWN). NO SUBSEQUENT ADVERSE EVENT REPORT WAS RECEIVED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT#: (B)(4). H6. COMPONENT CODE: G07002 - DEVICE NOT RETURNED. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: HOW LONG WAS THE DELAY? PLEASE SPECIFY IN MINUTES. WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE PROLONGED SURGERY TIME? WERE THERE PATIENT CONSEQUENCES? IF YES, PLEASE SPECIFY. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC VALVE BIOLOGICAL VALVE REPLACEMENT PROCEDURE ON (B)(6) 2025 AND A SUTURE WAS USED. THE PATIENT WAS HOSPITALIZED IN OUR HOSPITAL DUE TO CHEST TIGHTNESS AND UNDERWENT SURGERY. DURING THE OPERATION, WHEN THE DOCTOR WAS SUTURING THE PATIENT, THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED DURING THE SUTURING PROCESS AND COULD NO LONGER BE USED. THE BROKEN NEEDLE AND THREAD WERE REMOVED AND REPLACED WITH A NEW ONE FOR SUTURING, WHICH PROLONGED THE OPERATION TIME AND COULD EASILY CAUSE THE PATIENT TO BLEED HEAVILY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.