BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM

    MDR report key: 9523212 · Received December 27, 2019

    Report

    Report Number
    2183870-2019-00604
    Event Type
    Injury
    Date Received
    December 27, 2019
    Date of Event
    December 20, 2019
    Report Date
    February 19, 2020
    Manufacturer
    COVIDIEN
    Product Code
    NIO
    UDI-DI
    00643169787841
    PMA / PMN Number
    P030045
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION THE VISI PRO INSERTED THE BOX LABELED A873079 WAS INSPECTED. THE VISI PRO CATHETER WAS RETURNED WITHOUT A STENT LOADED OVER THE BALLOON. THE BALLOON WAS EXPANDED AND LIKELY PREVIOUSLY INFLATED. THE BALLOON APPEARED TO HAVE BEEN INFLATED PREVIOUSLY. THE EXTERIOR OF THE VISI-PRO SHOWED DRIED BLOOD ADHERED TO THE CATHETER AND BALLOON. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: PREOPERATIVE DIAGNOSIS REPORTED AS ULCERATION IN LEFT BELOW-THE-KNEE AMPUTATION WITH BILATERAL COMMON ILIAC ARTERY STENOSES AND AORTOILIAC OCCLUSIVE DISEASE BASED ON DUPLEX. THE PATIENT WAS SEDATED. BOTH GROINS WERE PREPPED AND DRAPED. THE RIGHT COMMON FEMORAL ARTERY WAS ACCESSED WITH A LARGE-BORE NEEDLE AND A 6 FRENCH SHEATH WAS INSERTED. AORTOGRAM WAS OBTAINED. THE BIFURCATION WAS CROSSED WITH A NON-MEDTRONIC CATHETER AND SELECTIVE LEFT LEG ANGIOGRAPHY WAS OBTAINED WITH THE CATHETER TIP IN THE LEFT EXTERNAL ILIAC ARTERY. AFTER REVIEW, THE PATIENT'S STUMP HEPARINIZED. THE LEFT FEMORAL ARTERY WAS ACCESSED WITH A LARGE-BORE NEEDLE AND A LONG 6 FRENCH SHEATH WAS INSERTED. INITIAL PLANS WAS FOR BILATERAL KISSING BALLOON ANGIOPLASTIES. BOTH STENTS WERE INSERTED IN APPROPRIATE LOCATION. FOLLOWING STENT DISLODGEMENT, AN EXTENDED AMOUNT OF TIME WAS REQUIRED TO RECAPTURE THE STENT. THIS INCLUDED SNARING THE CONTRALATERAL LIMB WIRE. THE SECOND STENT DISLODGED AT A LOCATION SLIGHTLY LOWER THAN PLANNED. THE TWO ADDITIONAL STENTS DEPLOYED ALLOWED TO CREATE A DOUBLE BARREL REPAIR. THE STENTS WERE POST DILATED TO 10 MM WITH GOOD RESULT. BOTH SHEATHS WERE THEN REMOVED, AND CLOSING WAS PERFORMED. PROTAMINE WAS ADMINISTERED. PATIENT RECEIVED 115 CC OF CONTRAST. PATIENT HAD 100 CC OF BLOOD LOSS WHICH IS MOSTLY THROUGH THE SNARE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION STENT EXPLANTATION WILL NOT BE PERFORMED. THE PATIENT IS REPORTED TO BE DOING FINE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PHYSICIAN WAS USING VISI PRO BALLOON EXPANDABLE STENTS ALONG WITH NON MEDTRONIC 6FR SHEATH AND GUIDE WIRE DURING PROCEDURE TO TREAT LITTLE CALCIFIED PLAQUE LESION IN THE LEFT PROXIMAL COMMON ILIAC WITH 60% STENOSIS. THE VESSEL DIAMETER AND LESION LENGTH IN THE LEFT LEG WAS 8MM AND 30MM RESPECTIVELY AND 8MM AND 15MM ON THE RIGHT LEG RESPECTIVELY. THE DEVICES WERE PREPPED PER IFU WITH NO ISSUES NOTED. IT WAS REPORTED THAT DURING DELIVERY OF DEVICE TO LESION IN THE LEFT LIMB, THE STENT DISLODGED. AS THE STENT WAS BEING RE-POSITIONED TO DEPLOY, THE BALLOON DISLODGED FROM STENT. THE STENT WAS THEN PARTIALLY DEPLOYED AND BALLOON ADVANCED AND REST OF STENT EXPANDED. STENT EXPANDED WITH BALLOON ONLY PARTIALLY IN STENT THEN BALLOON ADVANCED AND REST OF STENT EXPANDED. DURING DELIVERY OF SECOND STENT TO THE RIGHT LIMB IT ALSO DISLODGED. IT WAS REPORTED THAT AN ATTEMPT TO REMOVE ADVANCED DEVICE AS PHYSICIAN DECIDED TO USE A LONGER STENT, THE STENT DISLODGED FROM BALLOON. AN ATTEMPT TO ADVANCE BALLOON BACK THROUGH THE STENT FAILED BUT BALLOON THE PUSHED STENT INTO AORTA. PHYSICIAN USED A SNARE OPPOSITE SIDE TO HELP WITH ABILITY TO PUSH THE BALLOON INTO THE UNEXPANDED STENT WHICH IS IN PROXIMAL AORTA. 2 9X57 STENTS WERE PLACED FROM COMMON ILIACS INTO STENT THAT WAS DEPLOYED IN AORTA. STENTS WERE DEPLOYED AND PREVIOUS DEPLOYED STENT EXPANDED TO FULL WALL APPOSITION. BOTH THE 8X27 AND 8X17 VISIPRO STENTS WERE PLACED THROUGH CORRECT SHEATH SIZED 6FR. UPON RE-POSITIONING, BOTH DEVICES DISLODGED FROM BALLOON. BOTH DEVICES WERE PREPPED PER IFU WITH NO ISSUES IDENTIFIED. BILATERAL LESIONS WERE NOT PRE DILATED. BOTH DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENTS AND NO FORCES USED WHILE ADVANCING DEVICES. STENT EXPLANTATION WILL BE PERFORMED. NO FURTHER PATIENT INJURY WAS REPORTED FOR THIS EVENT .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319869 VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM STENT, ILIAC NIO COVIDIEN PXB35-08-17-135 A873079 00643169787841

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention