BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBRA PZF

    MDR report key: 8185461 · Received December 20, 2018

    Report

    Report Number
    3009306400-2018-00077
    Event Type
    Injury
    Date Received
    December 20, 2018
    Date of Event
    November 19, 2018
    Report Date
    March 7, 2019
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    UDI-DI
    00879397007233
    PMA / PMN Number
    160014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H2 ADDITIONAL INFORMATION: H6 RESULTS CODE 3233 REPLACED WITH 3221. H6 CONCLUSION CODE 11 REPLCED WITH 3415. THE STENT REMAINS IN THE PATIENT AND THE DELIVERY SYSTEM WAS REQUESTED FOR RETURN, BUT HAD BEEN DISCARDED BY THE SITE. A REVIEW OF THE LOT HISTORY RECORD (LHR) WAS PERFORMED. THERE WERE NO NON-CONFORMANCES. THE LOT CONFORMS TO ITS PREDETERMINED SPECIFICATIONS AND REQUIREMENTS, INCLUDING FOR CROSSING PROFILE AND STENT RETENTION. INABILITY TO CROSS AND DISLODGEMENT ARE CAPTURED IN THE RISK ASSESSMENT AS KNOWN POTENTIAL HAZARDS. MYOCARDIAL INFARCTION (MI) AND INABILITY TO DELIVER STENT TO INTENDED SITE ARE KNOWN POTENTIAL ADVERSE EVENTS RELATED TO PERCUTANEOUS CORONARY INTERVENTIONS. ANGIOGRAPHY WAS RECEIVED AND REVIEWED BY CELONOVA MEDICAL AFFAIRS. MULTI-VESSEL CORONARY ARTERY DISEASE OBSERVED WITH SEVERE STENOSIS AT MID RCX, AND OSTIAL RCX. ANGIOGRAPHY SHOWS POOR VASCULARIZATION DISTAL TO RCX REMAINS. A STENT SYSTEM IS SEEN ADVANCED IN THE LEFT MAIN. NO ADDITIONAL IMAGES ARE SEEN PAST ADVANCEMENT INTO THE LEFT MAIN. THE REPORTED EVENT WAS NOT CAPTURED IN THE PROVIDED ANGIOGRAPHY IMAGES. THE INVESTIGATION DETERMINED THAT WHILE A DEFINITIVE CONCLUSIVE CAUSE IS NOT ABLE TO BE ASSIGNED TO THE REPORTED COMPLAINT, THE REPORTED INABILITY TO CROSS WITH STENT DISLODGEMENT ARE LIKELY ATTRIBUTED TO THE SEVERE VESSEL TORTUOSITY AND POSSIBLY DUE TO SHARP ANGULATION OF TAKE-OFF TO TARGET VESSEL. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING; THERE IS NO EVIDENCE OF A DEVICE DEFICIENCY.

    Description of Event or Problem · 0

    A 74-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY OF MULTI-VESSEL CORONARY ARTERY DISEASE, WITH SEVERAL PRIOR PERCUTANEOUS CORONARY INTERVENTIONS (PCI) OF MID RIGHT CORONARY ARTERY (RCA) AND RAMUS CIRCUMFLEX (RCX), PRESENTED WITH UNSTABLE ANGINA AND OCCLUSION OF THE MID RCA AND SUBTOTAL OSTIAL RCX STENOSIS AS WELL AS HIGH GRADE BIFURCATION STENOSIS AT RCX/M1. THE PATIENT WAS SCHEDULED FOR SURGICAL INTERVENTION WHEN THE PHYSICIAN OPTED TO ALTERNATIVELY IMPLANT A COBRA PZF STENT IN THE RCX. AFTER PRE-DILATING THE LESION, A 2.5X18MM COBRA PZF STENT SYSTEM WAS ADVANCED VIA FEMORAL ACCESS TOWARD A SEVERELY CALCIFIED LESION IN THE SEVERELY TORTUOUS OSTIAL RAMUS CIRCUMFLEX (RCX) CORONARY ARTERY, WHEN RESISTANCE WAS FELT; WHEN RETRACTING THE STENT SYSTEM, THE STENT DISLODGED BETWEEN THE LEFT MAIN (LM) CORONARY ARTERY AND THE RCX OSTIUM. THE PATIENT EXPERIENCED CARDIAC ENZYME ELEVATION (TROPONIN INCREASE), WHICH WAS CONFIRMED TO BE A MYOCARDIAL INFARCTION. THE STENT WAS FOUND AND CRUSHED AGAINST THE OSTIAL RCX. THE TARGET LESION WAS TREATED VIA DEPLOYMENT OF A 3.0X9MM DRUG-ELUTING STENT. THE MID RCA WAS UNABLE TO BE SUCCESSFULLY RECANALIZED. PER THE TREATING PHYSICIAN, THIS WAS A COMPLEX CASE, OVERALL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IN THE PATIENT AND THE DELIVERY SYSTEM WAS REQUESTED FOR RETURN, BUT HAS NOT BEEN RECEIVED. A REVIEW OF THE LOT HISTORY RECORD (LHR) WAS PERFORMED. THERE WERE NO NON-CONFORMANCE'S. THE LOT CONFORMS TO ITS PREDETERMINED SPECIFICATIONS AND REQUIREMENTS, INCLUDING FOR CROSSING PROFILE AND STENT RETENTION. INABILITY TO CROSS AND DISLODGEMENT ARE CAPTURED IN THE RISK ASSESSMENT AS KNOWN POTENTIAL HAZARDS. MYOCARDIAL INFARCTION (MI) AND INABILITY TO DELIVER STENT TO INTENDED SITE ARE KNOWN POTENTIAL ADVERSE EVENTS RELATED TO PERCUTANEOUS CORONARY INTERVENTIONS. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE FILED WITH ADDITIONAL RELEVANT

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT WITH A MEDICAL HISTORY OF 2-VESSEL CORONARY ARTERY DISEASE, WITH SEVERAL PRIOR PERCUTANEOUS CORONARY INTERVENTIONS (PCI) OF RIGHT CORONARY ARTERY (RCA) AND RAMUS CIRCUMFLEX (RCX) SINCE 1994 PRESENTED WITH UNSTABLE ANGINA AND OCCLUSION OF THE MID RCA AND SUBTOTAL STENOSIS OF THE RCX. THE PATIENT WAS SCHEDULED FOR SURGICAL INTERVENTION WHEN THE PHYSICIAN OPTED TO ALTERNATIVELY IMPLANT A COBRA PZF STENT IN THE RCX. AFTER PRE-DILATING THE LESION, A 2.5X18MM COBRA PZF STENT SYSTEM WAS ADVANCED VIA FEMORAL ACCESS TOWARD A SEVERELY CALCIFIED LESION IN THE SEVERELY TORTUOUS OSTIAL RAMUS CIRCUMFLEX (RCX) CORONARY ARTERY, WHEN RESISTANCE WAS FELT; WHEN RETRACTING THE STENT SYSTEM, THE STENT DISLODGED BETWEEN THE LEFT MAIN (LM) CORONARY ARTERY AND THE RCX. THE PATIENT EXPERIENCED CARDIAC ENZYME ELEVATION (TROPONIN INCREASE), WHICH WAS CONFIRMED TO BE A MYOCARDIAL INFARCTION. ANGIOGRAPHY WAS PERFORMED TO LOCATE THE STENT; IT WAS FOUND AND CRUSHED AGAINST THE VESSEL WALL. THE TARGET LESION WAS LEFT UNTREATED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1025402 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. NA 1704134001 00879397007233

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention