BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 14704624 · Received June 15, 2022

    Report

    Report Number
    3015053858-2022-00033
    Event Type
    Death
    Date Received
    June 15, 2022
    Date of Event
    May 4, 2022
    Report Date
    May 6, 2022
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    PPN
    PMA / PMN Number
    K203365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE M5+ IVL PERIPHERAL CATHETER WAS NOT RETURNED BY THE REPORTING PARTY. THEREFORE, PHYSICAL INVESTIGATION OF THE DEVICE COULD NOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED, THERE WAS NO ALLEGED MALFUNCTION OF THE DEVICE. THE LIKELY CAUSE FOR THE REPORTED PERFORATION AND SUBSEQUENT DEATH IS DUE TO OFF-LABEL USE OF THE M5+ IVL PERIPHERAL CATHETER BEING USED IN THE AORTIC VALVE. FURTHERMORE, IVL WAS PERFORMED AT 6 ATM'S WHICH IS HIGHER THAN THE TREATMENT PRESSURE OF 4 ATM PER THE DEVICE IFU. PER THE M5+ IVL CATHETER IFU, "THE SHOCKWAVE M5+ PERIPHERAL IVL SYSTEM IS INDICATED FOR LITHOTRIPSY-ENHANCED, LOW PRESSURE BALLOON DILATATION OF LESIONS, INCLUDING CALCIFIED LESIONS, IN THE PERIPHERAL VASCULATURE, INCLUDING THE ILIAC, FEMORAL, ILIO-FEMORAL, POPLITEAL, INFRA-POPLITEAL, AND RENAL ARTERIES. THIS DEVICE IS NOT INTENDED FOR USE IN CORONARY, CAROTID, OR CEREBROVASCULAR ARTERIES." THE PHYSICIAN BELIEVES THAT TRYING TO ADVANCE THE SHEATH THROUGH THE LEAK TO DEPLOY THE PLUG TORE THE CHUNK OF CALCIUM WHICH LED TO THE CAUSE OF THIS EVENT. SHOCKWAVE MEDICAL HAS CONTROLS IN PLACE TO ENSURE DEVICES ARE BUILT TO APPROVED PROCEDURES AND MEET LOT RELEASE ACCEPTANCE CRITERIA PRIOR TO BEING DISTRIBUTED. A REVIEW OF THE MANUFACTURING AND TEST DOCUMENTATION FOR SUBJECT LOT DOES NOT REVEAL ANY ISSUES WITH THE MANUFACTURING OF THE DEVICE. THE DEVICE PASSED ALL OF SHOCKWAVE MEDICAL, INC. ACCEPTANCE CRITERIA PRIOR TO SHIPPING.

    Description of Event or Problem · 0

    AN M5+ IVL PERIPHERAL CATHETER WAS USED FOR AN AORTIC VALVULOPLASTY TO FRACTURE CALCIUM BEHIND THE RECENTLY PLACED TAVR TO SEAL A PVL, WHICH IS OUTSIDE THE INDICATIONS FOR USE FOR THE M5+ DEVICE. THE PHYSICIAN WAS NOTIFIED OF THE OFF-LABEL USE OF THE DEVICE. IVL WAS PERFORMED WITH TWO M5+ CATHETERS USING 160 PULSES AT 6ATMS, AND POST-DILATION WAS PERFORMED 20 MM Z MED. 20 ATM. POST IVL, PVL (PERIVENTRICULAR LEUKOMALACIA) WAS STILL PRESENT SO THE PHYSICIAN CONTINUED WITH THE PROCEDURE WITH ATTEMPTS TO WIRE THE PVL AND SEAL WITH AN AMPLATZER PLUG. UPON ATTEMPTS TO ADVANCE THE SHEATH OVER THE WIRE AND THROUGH THE PVL, A GRADE IV PERFORATION AND EFFUSION WAS OBSERVED AT THE FOCAL-CORONARY SINUS. THE PERFORATION WAS NOT RESOLVED. THE PHYSICIAN BELIEVES THAT TRYING TO ADVANCE THE SHEATH THROUGH THE LEAK TO DEPLOY THE PLUG TORE THE CHUNK OF CALCIUM WHICH LED TO THE CAUSE OF THIS EVENT. CPR WAS ADMINISTERED AND THE PATIENT ULTIMATELY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1129869 SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER PPN SHOCKWAVE MEDICAL, INC. M5PIVL8060 A210802B

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Death| O 20MM BALLOON- ZMED