BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    MDR report key: 17914103 · Received October 11, 2023

    Report

    Report Number
    2024168-2023-11195
    Event Type
    Injury
    Date Received
    October 11, 2023
    Date of Event
    September 21, 2023
    Report Date
    November 14, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    UDI-DI
    08717648235184
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORDS IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES [DIFFICULT TO OPEN OR CLOSE THE FOOT AND DEVICE ENTRAPMENT]; HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. D4 - LOT# UPDATED FROM 3060142 TO LOT#3060143.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORDS IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES [DIFFICULT TO OPEN OR CLOSE THE FOOT AND DEVICE ENTRAPMENT]; HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. ATTACHMENT: USER FACILITY MEDWATCH REPORT # (B)(4).

    Description of Event or Problem · 0

    SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED. HOSPITALIZATION WAS EXTENDED AS A RESULT OF THE ISSUE WITH THE PROSTYLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THIS WAS AN ARTERIOTOMY CLOSURE OF THE MILDLY CALCIFIED RIGHT COMMON FEMORAL ARTERY (RCFA) USING THE PRE-CLOSE TECHNIQUE VIA AN 8F SHEATH HOLE PRIOR TO A PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH IMPELLA PROCEDURE. THE PATIENT WAS IN CARDIOGENIC SHOCK. REPORTEDLY, WHEN ATTEMPTING TO REMOVE THE PROSTYLE DEVICE AFTER SUTURE DEPLOYMENT, IT WAS STUCK AND COULD NOT BE REMOVED. THE LEVER WAS CLOSED COMPLETELY; HOWEVER, IT WAS THOUGHT THAT THE FOOT DID NOT RETRACT. ATTEMPTS WERE MADE TO OPEN AND CLOSE THE FOOT AS WELL AS ADVANCING THE DEVICE; HOWEVER, THE FOOT STILL DID NOT CLOSE. ACCESS IN THE LEFT COMMON FEMORAL ARTERY WAS OBTAINED AND A HEART PUMP WAS PLACED. THE PCI PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS THEN TAKEN TO THE OPERATING ROOM AND SURGICAL CUT DOWN SURGERY WAS PERFORMED TO REMOVE THE STUCK PROSTYLE DEVICE FROM THE RCFA. DURING THE CUT DOWN SURGERY, IT WAS CONFIRMED THAT THE FOOT REMAINED OPENED EVEN THOUGH THE LEVER HAD BEEN ABLE TO BE CLOSED COMPLETELY. THE FOOT WAS STILL INTACT AND NOTHING HAD SEPARATED. THE DEVICE WAS SURGICALLY REMOVED AND HEMOSTASIS WAS ACHIEVED WITH SURGICAL SUTURING. THERE WAS A REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AS A RESULT OF THE CUT DOWN SURGERY. A USER FACILITY MEDWATCH REPORT # (B)(4) WAS ALSO RECEIVED FOR THIS EVENT AND STATES: "TRYING TO DEPLOY THE PERCLOSE DEVICE FOR IMPELLA DEVICE. DEVICE GOT STUCK IN THE ARTERY WALL. COULDN'T REMOVE IT. PATIENT WENT TO VASCULAR SURGERY. GIVEN THE PRE-EXISTING RIGHT FEMORAL IABP (INTRA-AORTIC BALLOON PUMP) INSERTION, I REMOVED THE IABP UNDER DIRECT FLUOROSCOPIC VISUALIZATION WITH A WIRE THROUGH THE SIDE PORT. I THEN PLACED A 9-FRENCH SHEATH TO OBTAIN A FEMORAL ANGIOGRAM. THE ARTERIOTOMY WAS IMMEDIATELY SUPERIOR TO THE BIFURCATION. I THEN PLACED ONE PERCLOSE WITHOUT DIFFICULTY. UPON PLACING THE SECOND PERCLOSE, THE FOOTPLATE BECAME ENTRAPPED IN THE ARTERIAL WALL. ATTEMPTS TO INTENTIONALLY OPEN THE FOOTPLATE, ADVANCE IT, THEN CLOSE THE FOOTPLATE WAS UNSUCCESSFUL. VASCULAR SURGERY WAS IMMEDIATELY NOTIFIED. GIVEN THE ONGOING SITUATION, I THEN SWITCH TO THE LEFT FEMORAL ACCESS TO PLACE THE IMPELLA. WHAT WAS THE ORIGINAL INTENDED PROCEDURE?: REMOVAL OF IABP DEVICE/ INSERTION OF IMPELLA. WHAT PROBLEM DID THE USER HAVE?: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING)". WHAT PROBLEM DID THE USER HAVE?: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180070 PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 3060143 08717648235184

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Hospitalization| R PROSTYLE SUTURE