BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX SUTURE

    MDR report key: 10898831 · Received November 24, 2020

    Report

    Report Number
    3003910212-2020-01137
    Event Type
    Injury
    Date Received
    November 24, 2020
    Date of Event
    October 17, 2020
    Report Date
    April 22, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    GAW
    PMA / PMN Number
    P820083
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AN EXPLANT EVALUATION WAS PERFORMED, HISTOPATHOLOGICAL EXAMINATION WAS PERFORMED FOR EACH SUTURE FRAGMENT. THE SUTURE FRAGMENTS WERE GROSSLY DEVOID OF TISSUE. THE SECTIONS EXAMINED CONTAINED ACELLULAR PROTEINACEOUS FLUID IN THE EPTFE INTERSTICES WITH NO EVIDENCE OF MINERALIZATION OR COLLAGENOUS INFILTRATION. THERE WAS NO EVIDENCE OF INFLAMMATION. THIS WOULD BE THE EXPECTED TISSUE RESPONSE FOR SUTURE BIOMATERIAL RELATIVELY DISTANT FROM TISSUE INSERTION (I.E. MID-VENTRICLE FOR CHORDAE REPLACEMENT). THE SUTURE FRAGMENTS WERE SUBJECTED TO AN ACID DIGESTION PROCESS TO REMOVE BIOLOGIC DEBRIS. FOLLOWING DIGESTION, THE FRAGMENTS WERE EXAMINED FOR MATERIAL DISRUPTIONS USING A STEREOMICROSCOPE AND SCANNING ELECTRON MICROSCOPY. BOTH SUTURE FRAGMENTS HAD AREAS OF COMPRESSION AND INDENTATION PRESENT. THE AREAS OF COMPRESSION AND INDENTATION PRESENT ON BOTH SUTURE FRAGMENTS WERE CONSISTENT WITH THOSE CAUSED BY MECHANICAL INTERVENTION VIA SURGICAL INSTRUMENTATION (I.E., FORCEPS, CLAMPS). EXTREMITY A OF SF-1 WAS TAPERED TO AN IRREGULAR, FRAYED, THIN EDGE, WITH MATERIAL ELONGATING FROM THE EXTREMITY EDGE. THE ELONGATION AND TAPERING OF THE MATERIAL WITH A FRAYED, THIN EDGE WAS CONSISTENT WITH MATERIAL THAT HAD BEEN PULLED/TENSIONED, PRIOR TO RUPTURING. THE CAUSE AND TIMING OF THE RUPTURE CANNOT BE DETERMINED WITH INFORMATION PROVIDED. ALL OTHER EXTREMITIES PRESENTED WITH SMOOTH, FLAT-FACED, OVOID EDGES. THE EDGES ARE CONSISTENT WITH TRANSECTIONS CAUSED BY SHARP SURGICAL INSTRUMENTS (I.E., SCISSORS), LIKELY USED DURING A SURGICAL PROCEDURE. THE SUTURE WAS GROSSLY DEVOID OF TISSUE. THE SECTIONS EXAMINED CONTAINED ACELLULAR PROTEINACEOUS FLUID IN THE EPTFE INTERSTICES WITH NO EVIDENCE OF MINERALIZATION OR COLLAGENOUS INFILTRATION. THERE WAS NO EVIDENCE OF INFLAMMATION. THE EXACT SERIAL NUMBER FOR THE SUTURE FRAGMENTS RETURNED CAN NOT BE DETERMINED WITH THE INFORMATION PROVIDED. W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE INSTRUCTIONS FOR USE (IFU) FOR THE GORE-TEX® SUTURE, "AS WITH ANY SUTURE, CARE SHOULD BE TAKEN TO AVOID DAMAGE WHEN HANDLING. AT LEAST SEVEN, EQUALLY TENSIONED, FLAT SQUARE THROWS ARE REQUIRED TO PRODUCE A SECURE KNOT WHEN TYING GORE-TEX® SUTURE FOR CHORDAE TENDINEAE REPAIR OR REPLACEMENT. ADDITIONAL THROWS MAY BE NECESSARY DEPENDING ON SURGICAL CIRCUMSTANCES. WHEN TYING KNOTS WITH THE GORE-TEX® SUTURE, TENSION SHOULD BE APPLIED BY PULLING EACH STRAND OF THE SUTURE IN OPPOSITE DIRECTIONS WITH EQUAL FORCE. AS THE KNOT IS TENSIONED, THE AIR IN THE SUTURE IS FORCED OUT. CARE SHOULD BE TAKEN TO AVOID USING A JERKING MOTION WHICH COULD BREAK THE SUTURE. UNEVEN TENSIONING OF A WELL FORMED SQUARE KNOT MAY RESULT IN AN UNSECURE KNOT. WHEN THE GORE-TEX® SUTURE IS PROPERLY TENSIONED AND FORMED, STANDARD SURGICAL KNOTTING TECHNIQUES WILL PRODUCE A SECURE KNOT."

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2019, THIS PATIENT UNDERWENT ARTIFICIAL VALVE CHORDAE TENDINEAE USING GORE-TEX® SUTURE (CV-5) FOR MITRAL INSUFFICIENCY. (B)(6) 2020, THE PATIENT PRESENTED WITH RECURRENCE OF BREATH SHORTNESS. UPON EXAMINATION, THE CHORDAE TENDINEAE WERE BROKEN. THE CV-5 WAS EXPLANTED AND THE CHORDAE TENDINEAE WAS RECONSTRUCTED USING GORE-TEX SUTURE (CV-4). THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED AS FOLLOWS: I HAD AN IMPRESSION THAT THE SUTURE BROKE IN ONE YEAR WAS A LITTLE BIT TOO EARLY. I WOULD BE GRATEFUL IF YOU COULD TELL ME WHAT GORE THINK OF AS THE CAUSE OF THE BREAKAGE. THE REPORTED DEVICE WILL BE RETURNED TO GORE FOR FURTHER INVESTIGATION. A PHYSICIAN LETTER WAS REQUESTED. THESE WERE REQUESTED TO DESCRIBE IN THE LETTER, SEM OF THE TORN SURFACE, INSPECTION BY STAINING, PRESENCE OF CALCIFICATION, RESULT OF PRODUCT HISTORY REVIEW, POSSIBLE CAUSES OF THE BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363268 GORE-TEX SUTURE SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| O