BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRLNE BLU 36IN 5-0 D/A RB-1

    MDR report key: 16117401 · Received January 6, 2023

    Report

    Report Number
    2210968-2023-00155
    Event Type
    Death
    Date Received
    January 6, 2023
    Date of Event
    December 18, 2022
    Report Date
    January 24, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    UDI-DI
    10705031017030
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, 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. (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? WHAT WAS THE INITIAL APPROACH FOR THE INDEX SURGICAL PROCEDURE? (OPEN, LAPAROSCOPIC OR OTHER)? ON WHAT TISSUE WAS THE SUTURE USED? WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? HOW WAS THE SUTURE PLACED (INTERRUPTED OR CONTINUOUS)? HOW WAS THE SUTURE ORIGINALLY TIED (MULTIPLE KNOTS, SQUARE KNOT, ETC.)? PLEASE DESCRIBE ANY MEDICAL/SURGICAL INTERVENTION REQUIRED FOR THIS SUTURE EVENT INCLUDING DATES AND RESULTS. DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER SUTURE PLACEMENT? WHAT SYMPTOMS DID THE PATIENT EXPERIENCE FOLLOWING THE INDEX SURGICAL PROCEDURE? ONSET DATE? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? LOT NUMBER? IF APPLICABLE, WILL PRODUCT BE RETURNED? IF SO, PLEASE PROVIDE THE RETURN DATE AND TRACKING INFORMATION. IS IT KNOWN IF THE SUTURES UNTIED, BROKE, OR PULLED OUT OF THE TISSUE? WERE THERE ANY PRECIPITATING STRESS FACTORS THAT LED TO THE SUTURE UNTYING, BREAKING OR PULLING OUT OF THE TISSUE? HAS AN AUTOPSY BEEN PERFORMED? IF SO, CAN THE RESULTS BE SHARED? WOULD THE PHYSICIAN LIKE TO SPEAK WITH ETHICON MEDICAL SAFETY AND ENGINEERING VIA SCHEDULED CONFERENCE CALL REGARDING THE PRODUCT INVOLVED IN THIS EVENT?

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, 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 WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WEEKS AGO, I APPROACHED BONNIE TO GET MORE INFORMATION ABOUT THIS COMPLAINT. SHE SAID THAT I WOULD HAVE TO TALK TO DR. (B)(6), INDICATING THAT SHE DIDN¿T HAVE ANYTHING TO ADD. SO, I FINALLY SPOKE TO DR. (B)(6) THIS WEEK AND MADE CLEAR TO HIM MY DUTY TO REPORT ANY COMPLAINT AND TO GET ADDITIONAL INFORMATION SO THAT WE CAN ENSURE SAFE AND EFFECTIVE PRODUCTS. HE WAS UNWILLING TO GIVE ME PATIENT SPECIFICS OR ANSWER THE QUESTIONS ABOVE. WHEN I PRESSED FOR MORE, HE SAID THAT THE SUTURE WHEN HE USED IT (ON FRIDAY 12/16) SEEMED COMPLETELY NORMAL. HE SAID THE PATIENT TISSUE WAS NORMAL AND IT WAS USED TO SECURE THE VALVE IN PLACE JUST AS IT NORMALLY FUNCTIONS. HE NOTICED NO ABNORMALITY. HE SAID SURGERY WENT WELL AND THERE WERE NO ISSUES WITH THE PATIENT UNTIL SUN MORNING 12/18, WHEN THEY BEGAN BLEEDING AND CRASHING. THEY RUSHED TO THE OR AND HE OPENED THE PATIENT BACK UP. HE SAID THAT HE THEN OBSERVED THAT THE SUTURE APPEARED TO HAVE HAD A ¿FRACTURE OR FRAYING IN IT¿. AGAIN, I TRIED TO GET MORE INFORMATION FOR THIS REPORT AND HE SAID HE DIDN¿T WANT TO PROCEED. SO, AT THIS POINT I BELIEVE THIS IS ALL THE INFORMATION I CAN GET. CORRECTED INFORMATION: H6 CLINICAL CODES AND HEALTH IMPACT CODES

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC VALVE REPLACEMENT SURGERY ON (B)(6) 2022 AND SUTURE WAS USED. EVERYTHING SEEMED FINE WITH THE SUTURE WHEN USED. THEN, THE SURGEON STATED THAT THE SUTURE MUST HAVE TORN BECAUSE THE PATIENT RUPTURED AND ENDED UP EXPIRING ON (B)(6) 2022. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437818 PRLNE BLU 36IN 5-0 D/A RB-1 SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. 8556H 10705031017030

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| D