BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 1203028 · Received October 17, 2008

    Report

    Report Number
    2134265-2008-03062
    Event Type
    Death
    Date Received
    October 17, 2008
    Date of Event
    August 15, 2008
    Report Date
    September 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME EVENT AS MFR REPORT #: 2134265-2008-03063 AND 2134265-2008-03064. IT WAS REPORTED THAT A PT DURING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURE, THREE BALLOON RUPTURES AND A DISSECTION OCCURRED. SUBSEQUENTLY TWO DAYS POST PROCEDURE THE PT DIED. THE PT PRESENTED WITH INCREASING ANGINA WITH KNOWN PRIOR CORONARY ARTERY DISEASE (CAD). PT WAS NOT A SURGICAL CANDIDATE DUE TO SEVERE O2 DEPENDENT CHRONIC OBSTRUCTIVE LUNG DISEASE (COPD). FOLLOWING ENTRY INTO THE LEFT GROIN, A RUNWAY 6F CLS 35-GUIDING CATHETER WAS USED TO ENGAGE THE LEFT MAIN CORONARY ARTERY. THE VESSEL WAS THEN WIRED WITH A 180 CM PT2 GUIDE WIRE, HOWEVER, ANOTHER MANUFACTURER'S 2.5 X 20MM BALLOON COULD NOT CROSS THE LESION. A 1.5 X 20MM MAVERICK2 MONORAIL BALLOON WAS THEN ADVANCED SUCCESSFULLY AND DILATED TO 15 ATMS. ON THE SECOND INFLATION, THE BALLOON RUPTURED "PROBABLY RELATED TO SPICULE CALCIFICATION". A SECOND 2 X 15 MAVERICK2 MR BALLOON WAS INFLATED AND ALSO RUPTURED. A MAILMAN GUIDE WIRE WAS USED AS A BUDDY GUIDE WIRE HOWEVER, BALLOON DIFFICULTIES CROSSING THE LESION WERE STILL ENCOUNTERED, INCLUDING THE UNSUCCESSFUL ADVANCEMENT OF A 2 X 20MM QUANTUM MAVERICK MR BALLOON. FINAL ANGIOGRAPHY SHOWED TIMI 3 FLOW "WITHOUT MUCH CHANGE FROM THE PRE-INTERVENTION." THE ENTRANCE SITE WAS THEN CLOSED. SHORTLY AFTER BEING REMOVED FROM THE TABLE, THE PT DEVELOPED SEVERE SUBSTERNAL CHEST DISCOMFORT AND EKG REVEALED ST ELEVATION IN THE ANTERIOR LEADS. ANGIOGRAPHY SHOWED THE LAD OCCLUDED AT THE PREVIOUS PTCA SITE. WITH DIFFICULTY THE LESION WAS RE-WIRED WITH A PT2 GUIDE WIRE FOLLOWING UNSUCCESSFUL ADVANCEMENT OF A MAILMAN GUIDE WIRE. A 2 X 15MM MAVERICK2 MR BALLOON WAS ADVANCED, BUT COULD NOT CROSS THE LESION. A SECOND MAILMAN GUIDE WIRE WAS USED AS A BUDDY WIRE, AND THE 2 X 15MM MAVERICK2 MR BALLOON WAS REINSERTED. UPON INFLATION, THE MAVERICK2 MR BALLOON RUPTURED. NO OTHER BALLOON WOULD CROSS THE LESION IN THE MID LAD. THERE APPEARED TO BE A DISSECTION AND PERHAPS THROMBUS IN THE VESSEL BUT THERE WAS TIMI 1 FLOW. ON FURTHER CONTRAST INJECTIONS, THERE APPEARED TO BE A DISSECTION WHICH EXTENDED BACK INTO THE LEFT MAIN CORONARY ARTERY. A 3 X 18MM OTHER MANUFACTURER'S STENT WAS IMPLANTED. A 2 X 12MM QUANTUM MAVERICK MR BALLOON WAS ADVANCED HOWEVER, IT COULD NOT CROSS THE LESION. THERE CONTINUED TO BE TIMI 1 FLOW IN THE DISTAL LAD. AN INTRA-AORTIC BALLOON PUMP WAS IMPLANTED FOR SUPPORT. THE PT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) FOR OBSERVATION. PT WAS TREATED WITH LISINOPRIL, PLAVIX, ASPIRIN AND STATIN, HOWEVER, A CHEST X-RAY SHOWED BILATERAL INFILTRATES. HE DEVELOPED WORSENING OF HIS CHRONIC KIDNEY DISEASE; DIURESE WAS ATTEMPTED HOWEVER, HE BECAME OLIGURIC. PT BECAME FLUID OVERLOADED DURING TREATMENT. PT WAS PUT ON DNR. PT WENT INTO RESPIRATORY FAILURE AND WAS SEVERELY ACIDOTIC, HYPERKALEMIC AND IN ACUTE RENAL FAILURE AND SEPTIC FROM UROSEPSIS AND PNEUMONIA. PT DIED TWO DAYS POST PROCEDURE; THE DEVICE RELATIONSHIP TO THE DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 MONORAIL PTCA CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC MAVERICK 20 / 1.5

    Patients

    Seq Age Sex Outcome Treatment
    1 Death QUANTUM MAVERICK BALLOONS| POWERSAIL 2.5 X 18MM BALLOON| MAILMAN GUIDE WIRES| VOYAGER BALLOON| CHOICE PT FLOPPY GUIDE WIRE| PT2 GUIDE WIRES