BEUDAMED
    FDA Adverse Event Death Summary report: N

    MICRA

    MDR report key: 9218264 · Received October 22, 2019

    Report

    Report Number
    9612164-2019-04461
    Event Type
    Death
    Date Received
    October 22, 2019
    Date of Event
    October 1, 2019
    Report Date
    November 28, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PNJ
    UDI-DI
    00643169711761
    PMA / PMN Number
    P150033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL DELIVERY SYSTEM WAS RETURNED AND ANALYZED. THE ANALYSIS INDICATED THAT THE DELIVERY SYSTEM OUTER SHAFT WAS BENT. THE ARTICULATION OF THE DELIVERY SYSTEM WAS OUT OF PLANE. THE LUMEN OF THE DELIVERY SYSTEM WAS DAMAGED. THERE WAS A VISUAL OBSERVATION WITH THE DELIVERY SYSTEM. BLOOD WAS OBSERVED ON THE INNER SHAFT OF THE DELIVERY SYSTEM. BLOOD WAS OBSERVED ON THE DEVICE CUP OF THE DELIVERY SYSTEM. BLOOD WAS OBSERVED ON THE RECAPTURE CONE OF THE DELIVERY SYSTEM. BLOOD WAS OBSERVED ON THE TETHER TUBE OF THE DELIVERY SYSTEM. VISUAL ANALYSIS OF THE DELIVERY SYSTEM INDICATED DAMAGE DURING USE. THE ANALYST NOTED THE FULL DELIVERY SYSTEM WAS RETURNED WITH THE DEVICE INTACT WITH THE TETHER BUT NOT FULLY RECAPTURED IN THE DEVICE CUP AND THE DEPLOYMENT BUTTON NOT IN THE RECAPTURE POSITION. THE OUTER SHAFT IS BENT AT 5 CM FROM THE DISTAL END OF THE DELIVERY SYSTEM. THERE IS CONTRAST ON THE OUT ER SHAFT LOCATED AT THE DISTAL END OF THE STABILITY MEMBER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. RETURNED PRODUCT ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: BRAND NAME: MICRA, MODEL #: MC1VR01 DELSYS / EXPIRATION DATE: 14 DEC 2020 / SERIAL#: (B)(4), UDI #: (B)(4). DEVICE AVAILABLE FOR EVALUATION: YES, RETURN DATE: 08 OCT 2019. DEVICE EVALUATED BY MANUFACTURER: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN DEV RTN TO MFR? YES. MFG DATE: 02 JUL 2019. LABELED FOR SINGLE USE: YES. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) USING A DELIVERY SYSTEM (DS) THE PATIENT DIED. IT WAS ALSO REPORTED THERE WAS AN ATYPICAL BEND IN THE DS PROXIMAL TO THE CONE DURING POSITIONING AND PREMATURE VENTRICULAR CONTRACTIONS WERE OBSERVED ON THE ELECTROCARDIOGRAM (ECG). THE IPG WAS DEPLOYED HOWEVER SMALL R WAVES AND NON CAPTURE WERE NOTED. THE IPG WAS HENCE RECAPTURED AND THE DS BEND WAS AGAIN NOTED. FOLLOWING RE POSITIONING THE IPG WAS DEPLOYED AGAIN WITH SIMILAR RESULTS TO THE INITIAL DEPLOYMENT SMALL R WAVES AND HIGH THRESHOLDS. FOLLOWING SOME DIFFICULTY ALIGNING THE DS AND IPG THE IPG WAS RECAPTURED. THE DS WAS AGAIN REPOSITIONED AND AT THIS TIME IT WAS NOTICED THAT THE PATIENT¿S HEART RATE HAD DECREASED TO 50-60 BEATS PER MINUTE BPM. THE PHYSICIAN COMMENTED THAT HE MUST HAVE BUMPED THE AV NODE WITH THE DS RESULTING IN HEART BLOCK. THE QRS COMPLEXES WERE NARROW. THE ANESTHESIOLOGIST COMMENTED THAT THE PATIENT LOOKED GRAY AND ANNOUNCED THAT THERE WAS NO BLOOD PRESSURE. THE PHYSICIAN LOOKED ON FLUOROSCOPY AND THE HEART WAS OBSERVED TO BE NOT MOVING DESPITE THE ECG SHOWING A HEART RATE OF 50-60 BPM. THE IPG AND DS WERE REMOVED. ULTRASOUND WAS USED TO CONFIRM A PERFORATION, PERICARDIAL EFFUSION AND CARDIAC TAMPONADE. THE NURSES ACTIVATED THE CODE ALARM. THE IMPLANTING PHYSICIAN INSERTED A PERICARDIAL DRAIN AND ASPIRATED BLOOD. RESUSCITATION EFFORTS INCLUDED CARDIOPULMONARY RESUSCITATION (CPR) WHEN THERE WAS NO PULSE OR BLOOD PRESSURE, INTERMITTENT ADMINISTRATION OF EPINEPHRINE, INFUSION OF INTRAVENOUS FLUIDS, BLOOD, AND DOPAMINE, AND ASPIRATION OF BLOOD FROM THE PERICARDIAL SPACE. APPROXIMATELY 4 LITERS OF BLOOD WERE REMOVED FR OM THE PERICARDIAL SPACE DURING THE RESUSCITATION EFFORT. THE PATIENT EXPIRED ON THE FLUOROSCOPY TABLE IN THE LAB DESPITE THESE EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012389 MICRA LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MC1VR01US 00643169711761

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death