BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2210855 · Received August 12, 2011

    Report

    Report Number
    2024168-2011-05717
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE TWO GRAFTMASTERS ARE EACH BEING FILED UNDER SEPARATE MFR NUMBERS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. THE PATIENT ANATOMY WAS HEAVILY CALCIFIED WHICH LIKELY CONTRIBUTED TO THE REPORTED FAILURE TO ADVANCE. HEMORRHAGE IS LISTED AS OBSERVED OR A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CORONARY STENTING IN THE GRAFTMASTER OTW INSTRUCTIONS FOR USE. DUE TO THE INHERENTLY EMERGENT AND SERIOUS USE OF THE GRAFTMASTER DEVICE, IT IS POSSIBLE THAT THE PERFORATION ITSELF AND/OR THE INABILITY TO TREAT THE PERFORATION MAY HAVE CONTRIBUTED TO THE REPORTED CASCADING PATIENT EFFECTS INCLUDING HEMORRHAGE. HOWEVER, A CONCLUSIVE CAUSE CANNOT BE DETERMINED FOR THE REPORTED PATIENT EFFECTS OR THEIR RELATIONSHIP TO THE DEVICE, IF ANY. A SEARCH OF THE LOT HISTORY RECORD INDICATED NO NON-CONFORMING MATERIAL REPORTS FOR THE LOT AND A SEARCH OF THE COMPLAINT DATABASE INDICATED NO RELATED INCIDENTS, THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. ALL STENT DELIVERY SYSTEMS ARE SUBJECTED TO A VISUAL INSPECTION. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS USED TO VERIFY THE PRODUCT QUALITY.

    Description of Event or Problem · 1

    REPORTEDLY A 3.0X12 MM GRAFTMASTER FAILED TO CROSS TO TREAT A PERFORATION LOCATED IN A SAPHENOUS VEIN GRAFT (SVG) TO THE OBTUSE MARGINAL (OM) BRANCH WHICH WAS EXTREMELY CALCIFIED. THE PERFORATION REPORTEDLY OCCURRED WHILE PLACING AN UNKNOWN 3.5 X18 MM BARE METAL STENT TO TREAT A LESION LOCATED IN THE SVG TO OM BRANCH. TWO 3.0X16 MM GRAFTMASTERS WERE PLACED AND SEALED THE AREA OF THE PERFORATION WHERE THEY WERE IMPLANTED, HOWEVER, THE LENGTH OF THE PERFORATION WAS LONGER THAN THE COMBINED LENGTH OF THE TWO GRAFTMASTERS AND THE SITE DID NOT HAVE ANY OTHER GRAFTMASTERS AVAILABLE TO TREAT THE PATIENT SO THE PERFORATION CONTINUED TO BLEED. THE PATIENT DIED LATER THAT DAY ALTHOUGH THE CAUSE OF DEATH IS UNKNOWN AT THIS TIME. NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT PRESENTED TO THE CATH LAB INITIALLY WITH CHEST PAIN AND ANEMIA. POST PROCEDURE THE PATIENT REPORTEDLY DIED FROM THE COMBINATION OF A RETROPERITONEAL BLEED AND ANEMIA. THE RETROPERITONEAL BLEED WAS TREATED WITH PRESSURE ONLY. NO CLOSURE DEVICE WAS USED. THE PERFORATION NEEDED THREE GRAFTMASTERS FOR TREATMENT, HOWEVER, THE SITE ONLY HAD THREE AVAILABLE AND WHILE TWO WERE SUCCESSFULLY IMPLANTED, THE THIRD ONE FAILED TO CROSS. THE REMAINDER OF THE PERFORATION WAS THEN TREATED WITH PROLONGED BALLOON INFLATIONS AND SURGERY WAS CONSIDERED, HOWEVER, THE PATIENT WAS DEEMED 'TOO HIGH RISK'. AFTER PROLONGED BALLOON INFLATIONS, THE PERFORATION WAS SEALED AND THE PATIENT WAS SENT TO THE ICU; HOWEVER, THE PATIENT WAS BROUGHT BACK TO THE CATH LAB BECAUSE THEY WERE EXPERIENCING A RETROPERITONEAL BLEED WHICH THE SITE TRIED TO TREAT WITH ADDITIONAL PRESSURE. HOWEVER, THE PATIENT ULTIMATELY DIED FROM THE BLEED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 656718

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention