BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1905062 · Received November 22, 2010

    Report

    Report Number
    2953144-2010-02946
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THAT BOTH CUFFS WERE STILL ATTACHED TO THE LINK AND RESPECTIVE NEEDLE TIPS. THERE WAS APPROXIMATELY 7 INCHES OF THE NON-RAIL PORTION OF THE SUTURE RETURNED AND THE REST OF THE MONOFILAMENT WAS NOT RETURNED. IT APPEARED THAT THE MONOFILAMENT WAS BROKEN AT THE KNOT PORTION AREA. SINCE THE REST OF THE MONOFILAMENT WAS NOT RETURNED, THE ROOT CAUSE COULD NOT BE DETERMINED. A SUTURE BREAK MAY OCCUR IF THE OPERATOR AGGRESSIVELY REMOVES THE PLUNGER OR USES EXCESSIVE SUTURE TENSION WHEN ADVANCING THE KNOT OR LOCKING THE KNOT BY PULLING THE WRONG END. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.(B)(4):DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA TRIAL THAT THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 90% STENOSIS, A LENGTH OF 8 MM, AND REFERENCE VESSEL DIAMETER OF 2.50 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION, PLACEMENT OF A 2.50 X 12 MM STUDY STENT, AND POST DILATATION WITH 9% RESIDUAL STENOSIS. THE SUBJECT WAS DISCHARGED ON (B)(6) 2009 ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2010, THE SUBJECT PRESENTED WITH THE COMPLAINT OF AN EPISODE OF EXERTIONAL CHEST PAIN. A STRESS ECHOCARDIOGRAM TEST ON (B)(6) 2010 INDICATED ANTERIOR WALL ISCHEMIA. ON (B)(6) 2010, 309 DAYS POST INDEX PROCEDURE, THE SUBJECT UNDERWENT CORONARY ANGIOGRAPHY WHICH REVEALED:9 0% MID STENOSIS PRIOR TO PREVIOUSLY PLACED STENT; MILD DISEASE IN REMAINDER OF VESSEL. TOTAL LESION REVASCULARIZATION: THE MID LAD WAS TREATED WITH A 2.5 X 12 MM PROMUS STENT WITH LESS THAT 10% RESIDUAL STENOSIS. THE SUBJECT WAS DISCHARGED ON (B)(6) 2010. NO ADDITIONAL INFORMATION WAS PROVIDED. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN THE NEEDLE PLUNGER WAS RETRACTED, A SUTURE BREAK OCCURRED. THE DEVICE WAS REMOVED AND HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION AND A NON-ABBOTT DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-REDWOOD CITY 930316H

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention