BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 7824899 · Received August 28, 2018

    Report

    Report Number
    2210968-2018-75507
    Event Type
    Injury
    Date Received
    August 28, 2018
    Report Date
    August 17, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PC-(B)(4). DATE SENT TO THE FDA: (B)(4) 2018¿ IT WAS REPORTED THAT THIS DEVICE IS NOT MALFUNCTION REPORTABLE. THEREFORE, THIS MEDWATCH REPORT 2210968-2018-75507 IS NOT REPORTABLE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED:THERE IS NO COMPLAINT WHATSOEVER. ANY ADVERSE REFERENCED IN THE PRODUCT ARE CATEGORICALLY NOT RELATED TO ANY PRODUCT BY ANY FIRM. RATHER THESE ARE EXPECTED FOLLOWING SURGERY USING ANY PRODUCT.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: INDIANHEARTJOURNAL68 (2016) 72¿76, HTTP://DX.DOI.ORG/10.1016/J.IHJ.2015.06.036 - [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: MID-TERM OUTCOMES OF PATIENTS UNDERGOING ADJUSTABLE PULMONARY ARTERY BANDING." AUTHORS: SACHIN TALWAR, NEERAJ ARAVIND KAMAT, SHIV KUMAR CHOUDHARY, SIVASUBRAMANIAN RAMAKRISHNAN, ANITA SAXENA, RAJNISH JUNEJA, SHYAM SUNDER KOTHARI, AND BALRAM AIRAN CITATION: INDIANHEARTJOURNAL68 (2016) 72¿76, HTTP://DX.DOI.ORG/10.1016/J.IHJ.2015.06.036. THE AIM OF THIS STUDY WAS TO ANALYZE THE OUTCOMES OF APAB IN THE MID-TERM IN TERMS OF THE REDUCTION OF PA PRESSURES AND SUITABILITY FOR DEFINITIVE PALLIATION AND TO STUDY THE BAND RELATED COMPLICATIONS ENCOUNTERED AT DEFINITIVE SURGERY. BETWEEN JANUARY 2002 UNTIL DECEMBER 2002, 73 PATIENTS UNDERWENT ADJUSTABLE PULMONARY ARTERY BAND (APAB) WERE INCLUDED IN THE STUDY. DURING THE PROCEDURE, THE MPA WAS LOOPED WITH A NO. 2 ETHIBOND ((B)(6)) SUTURE AFTER PASSING A RIGHT-ANGLE FORCEPS BETWEEN THE AORTA AND THE MPA. BOTH ARMS OF THE SUTURE WERE CLIPPED TOGETHER WITH A LIGACLIP (LT 200; ETHICON ENDOSURGERY (B)(6)) JUST ON THE PLEDGET. THESE SUTURES WERE BROUGHT OUT THROUGH THE PERICARDIUM AND THE LATERAL EDGE OF THE STERNUM AND THEN THROUGH SUBCUTANEOUS TISSUE AND SKIN. AFTER STERNAL CLOSURE, THE TWO ENDS OF THE SUTURE WERE PASSED THROUGH ANOTHER 1¿2 CM PTFE PLEDGET, AND THESE WERE CLIPPED TOGETHER WITH A BIG LIGACLIP (LT 400, ETHICON ENDOSURGERY). THE ENDS OF THE SUTURE WERE THEN TIED TO FORM A LOOP. SUBSEQUENT BAND TIGHTENING WAS ACHIEVED BY PLACING ADDITIONAL BIG LIGACLIPS BETWEEN THE EXTERNAL PTFE PLEDGET AND THE PREVIOUSLY PLACED LIGACLIP. ONCE SATISFACTORY GRADIENTS WERE ACHIEVED; THE BAND WAS INTERNALIZED BY SIMPLY OPENING ONE OF THE SKIN SUTURES, CLIPPING THE TWO ENDS OF THE ETHIBOND SUTURE AGAINST THE STERNUM USING A SMALL LIGACLIP, AND CUTTING THE ETHIBOND SUTURE ABOVE IT. THERE WAS 1 PATIENT HAD PSEUDOANEURYSM OF THE MAIN PULMONARY ARTERY (MPA) WITH STERNAL SINUS INFECTION AND REQUIRED SURGICAL RECONSTRUCTION. ONE PATIENT HAD INFECTIVE ENDOCARDITIS OF THE PULMONARY VALVE MANAGED MEDICALLY. IN CONCLUSION, PATIENTS UNDERGOING APAB ACHIEVED ADEQUATE PALLIATION OVER THE MID-TERM AND EITHER PROCEEDED TO OR WERE AWAITING DEFINITIVE REPAIR. SIGNIFICANT BAND-RELATED COMPLICATIONS WERE NOT ENCOUNTERED. THE TECHNIQUE OF APAB DESCRIBED BY US IS THUS ADVANTAGEOUS NOT ONLY IN THE SHORT-TERM AS DEMONSTRATED BY US PREVIOUSLY, BUT IS ALSO ASSOCIATED WITH ACCEPTABLE MIDTERM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666340 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention