BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 3110184 · Received May 13, 2013

    Report

    Report Number
    2024168-2013-03023
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    August 1, 2008
    Report Date
    April 19, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. PATIENT AGE AVERAGED AS 80 YEARS OLD. PATIENT GENDER MALE = 43%, FEMALE = 57%. CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: AMPLATZ SUPER STIFF ST-1; SHEATHS: 6-FRENCH, 7-FRENCH, 10-FRENCH, 18-FRENCH, 19-FRENCH; HEPARIN. THE DEVICES ARE NOT RETURNING. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. EVENT OR PROBLEM, CONTINUED: THE OCCURRENCE OF A MAJOR VASCULAR COMPLICATION LEADING TO DEATH WITHIN 30 DAYS OCCURRED IN 55.6% (N = 5) OF THE CASES TREATED BY STANDARD TECHNIQUE VERSUS 21.4% (N = 3) TREATED BY A DOUBLE ACCESS APPROACH (P = 0.10), RESPECTIVELY. RETROGRADE TREATMENT OF THE INJURED VESSEL SEGMENT COULD BE PERFORMED USING BALLOON DILATION AND/OR STENT IMPLANTATION (COVERED STENT GRAFT FOR SIGNIFICANT BLEEDING/PERFORATION, FENESTRATED STENT FOR DISSECTION). IN THE EVENT OF A COMPLICATION THAT COULD NOT BE MANAGED PERCUTANEOUSLY, A BALLOON CAN BE POSITIONED AND INFLATED WITHIN THE PROXIMAL ILIAC ARTERY TO ACHIEVE TEMPORARY HEMOSTASIS UNTIL SURGICAL RECONSTRUCTION IS PERFORMED IMMEDIATELY AFTERWARD. MINOR VASCULAR COMPLICATIONS OCCURRED IN A TOTAL OF 52 PTS (16.1%) WITH 10 PTS (7.5%) IN THE STANDARD GROUP AND 42 PTS (22.2%) IN THE DOUBLE ACCESS GROUP (P LESS THAN 0.05). REASONS FOR MINOR VASCULAR COMPLICATION WERE THE EXISTENCE OF A STENOSIS DUE TO THE SUTURE OF THE PERCUTANEOUS CLOSURE SYSTEM IN 20% (N = 2) OF THE STANDARD GROUP VS. 33.3% (N = 14) OF THE DOUBLE ACCESS GROUP (P LESS THAN 0.05), A SMALL DISSECTION OF THE FEMORAL ARTERY IN 30% (N = 3) OF THE STANDARD GROUP VS. 11.9% (N = 5) OF THE DOUBLE ACCESS GROUP (P = 0.09) OR A LEAKAGE DUE TO FAILURE OF THE PERCUTANEOUS CLOSURE SYSTEM IN 50% (N = 5) OF THE STANDARD GROUP VS. 54.8% (N = 23) OF THE DOUBLE ACCESS GROUP (P = 0.96). SUBSEQUENT TREATMENT BY VASCULAR SURGERY WAS NECESSARY WITH A RATE OF 20% IN THE STANDARD GROUP (N = 2) AND 2.4% (N = 1) IN THE DOUBLE ACCESS GROUP (P LESS THAN 0.05). ENDOVASCULAR STENTING WITHIN THE MINOR VASCULAR COMPLICATION GROUP WAS PERFORMED IN 60% (N = 6) FOR THE STANDARD GROUP VS. 40.5% (N = 17) FOR THE DOUBLE ACCESS GROUP (P = 0.79). A SINGLE BALLOON DILATATION (PTA) WAS DONE IN 20% (N = 2) OF THE STANDARD GROUP VS. 57% (N = 24) OF THE DOUBLE ACCESS GROUP (P LESS THAN 0.05). NO ADDITIONAL INFORMATION PROVIDED. CHRISTIAN FRERKER, MD, DIMITRY SCHEWEL, MD, KARL-HEINZ KUCK, MD, ULRICH SCHAFER, MD. (CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, 2013, 81:592-602) IPSILATERAL ARTERIAL ACCESS FOR MANAGEMENT OF VASCULAR COMPLICATION IN TRANSCATHETER AORTIC VALVE IMPLANTATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES WERE NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICES COULD NOT BE COMPLETED. REVIEWS OF THE LOT HISTORY RECORDS AND COMPLAINT HISTORY OF THE REPORTED LOTS COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBERS WERE NOT PROVIDED. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S) AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    THIS INFORMATION WAS OBTAINED THROUGH A LITERATURE REVIEW. A RETROSPECTIVE STUDY WAS PERFORMED BETWEEN AUGUST 2008 AND NOVEMBER 2011, A TOTAL OF 323 HIGH-RISK PATIENTS UNDERWENT A TAVI PROCEDURE. A TOTAL OF 134 PTS (41.5%) WERE TREATED WITH A STANDARD SINGLE PUNCTURE TECHNIQUE AND 189 (58.5%) PATIENTS WERE TREATED WITH THE NEW IPSILATERAL SECOND PUNCTURE TECHNIQUE (DOUBLE ACCESS GROUP). MAJOR VASCULAR COMPLICATIONS WERE EXISTENCE OF DISSECTION OF FEMORAL ARTERY IN SEVEN PTS (SINGLE PUNCTURE N = 2/9 [22.2%] VS. SECOND PUNCTURE N = 5/14 [35.7%], P = 0.50) AND LEAKAGE/PERFORATION OF ACCESS ARTERY OCCURRED IN ELEVEN PTS (STANDARD GROUP N = 4/9 [44.4%] VS. DOUBLE ACCESS GROUP N = 7/14 [50.0%]; P = 0.80). THERE WAS A NEED FOR VASCULAR SURGERY DUE TO ACCESS SITE VASCULAR INJURY OR FAILED PERCUTANEOUS TREATMENT IN 33.3% (N = 3) OF THESE VARC MAJOR CASES IN THE STANDARD GROUP VERSUS 21.4% (N = 3) IN THE DOUBLE ACCESS GROUP (P = 0.53). THE RATE OF PERCUTANEOUS TREATMENT (BALLOON BLOCKING OR STENT IMPLANTATION) WITHIN THE MAJOR VASCULAR COMPLICATION GROUP WAS 21.4% (N = 3) IN THE STANDARD GROUP COMPARED TO 64.2% (N = 9) IN THE DOUBLE ACCESS GROUP (P LESS THAN 0.05). THE PRESENCE OF A MAJOR VASCULAR COMPLICATION WAS ASSOCIATED WITH MUCH HIGHER 30-DAY MORTALITY IN BOTH GROUPS, HOWEVER STATISTICALLY NOT SIGNIFICANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209910 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention