BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK VISION CORONARY STENT SYSTEM

    MDR report key: 2800002 · Received October 22, 2012

    Report

    Report Number
    2024168-2012-06638
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    September 20, 2012
    Report Date
    September 24, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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. UPON INTRAVASCULAR ULTRA SOUND (IVUS), THE PROMUS STENT WAS NOTED TO BE UNDER EXPANDED IN THE PROXIMAL PORTION AND WAS POST-DILATED WITH A 3.5 X 12 MM NON-ABBOTT BALLOON AT 16 ATM AND A 4.0 X 8 MM NON-ABBOTT BALLOON AT 16 ATM. FINAL ANGIOGRAPHY NOTED TIMI 3 FLOW AND 0% RESIDUAL STENOSIS. THE PATIENT STATUS WAS REPORTED TO BE STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED. DIL CATH: BSC 2.5 X 12 MM NC QUANTUM, BSC 3.0 X 12 MM NC QUANTUM, BSC 2.5 X 12 MM NC SPRINTER, BSC 3.0 X 12 MM NC SPRINTER, BSC 3.0 X 9 MM NC SPRINTER, GUIDE WIRE: PROWATER, RUNTHROUGH, GUIDE CATH: CORDIS XB 3.5, MEDTRONIC AL1, SHEATH: 7 FRENCH. IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED STENOSIS AND ISCHEMIA ARE LISTED IN THE VISION INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING. THE PROMUS STENT REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN (B)(6) 2012, THE PATIENT HAD A 2.75 X 12 MM VISION STENT (UNSPECIFIED IF RX OR OTW) IMPLANTED IN THE LEFT CIRCUMFLEX ARTERY (LCX) AND HAD PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PERFORMED IN THE OBTUSE MARGINAL (OM1) WITH AN UNSPECIFIED 2.5 X 12 MM DEVICE. THE PATIENT RETURNED TO THE HOSPITAL WITH CHEST PAIN AND ISCHEMIA WAS NOTED. ANGIOGRAPHY NOTED SEVERE RESTENOSIS IN THE LCX-OM VESSEL. A NON-ABBOTT GUIDING CATHETER WAS ADVANCED AND A PROWATER GUIDE WIRE WAS PLACED IN THE DISTAL LCX AND A NON-ABBOTT GUIDE WIRE WAS PLACED IN THE OM1. PRE-DILATATION OF THE LESIONS IN THE LCX AND OM1 WAS PERFORMED USING A 2.5 X 10 MM NON-ABBOTT BALLOON AT 12 ATMOSPHERES (ATM). THE MINI-CRUSH TECHNIQUE WAS PERFORMED, IMPLANTING A 2.5 X 12 MM NON-ABBOTT STENT IN THE MID LCX AT 16 ATM. THEN THE 3.0 X 20 MM PROMUS STENT (UNSPECIFIED IF RX OR OTW) WAS POSITIONED AT THE LM-LCX. DURING PLACEMENT OF THE PROMUS STENT, THE STENT DISLODGED FROM THE BALLOON AT THE PROXIMAL PART OF THE STENT AND THE STENT WAS DEPLOYED AT THE LESION AT 16 ATM. POST-DILATATION WAS PERFORMED AT 16 ATM USING KISSING BALLOON TECHNIQUE WITH A 2.5 X 12 MM NON-ABBOTT BALLOON IN THE OM1 AND A 3.0 X 12 MM NON-ABBOTT BALLOON IN THE LM-LCX. DUE TO DEFLATION DIFFICULTIES WITH THE 3.0 X 12 MM NON-ABBOTT BALLOON, THE PATIENT EXPERIENCED HEMODYNAMIC INSTABILITY, REQUIRING 32MG OF NOREPINEPHRINE. KISSING BALLOON INFLATIONS WERE THEN PERFORMED WITH A 3.0 X 12 MM NON-ABBOTT BALLOON IN THE LM-LCX AND A 2.5 X 12 MM NON-ABBOTT BALLOON AT 6 ATM. THE OSTIUM OF THE OM1 WAS POST-DILATED WITH A 3.0 X 9 MM NON-ABBOTT BALLOON AT 12 ATM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R