BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROVASCULAR PLUG

    MDR report key: 24412580 · Received February 23, 2026

    Report

    Report Number
    9610849-2026-00045
    Event Type
    Injury
    Date Received
    February 23, 2026
    Date of Event
    February 16, 2026
    Report Date
    April 15, 2026
    Manufacturer
    COVIDIEN
    Product Code
    KRD
    UDI-DI
    00763000702106
    PMA / PMN Number
    K150108
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    IMAGE ANALYSIS THE ANGIOGRAPHY OF THE REINTERVENTION REVEALED A DISTAL MIGRATION OF THE 1ST MVP-7Q. THE 1ST MVP-7Q POSITION BEFORE MIGRATION SEEMED TO BE VERY STRAIGHT, NOT CURVED, AND PROVIDING AN EVEN WALL APPOSITION, ALL BENEFICIAL ASPECTS FOR THE PLACEMENT OF THE MVP IN THAT POSITION. THE ONLY THING THAT POSED A CHALLENGE, WAS AN INCREASED FLOW IN THESE VESSELS. THIS CAN ALSO BE SEEN IN THE REINTERVENTION, WHERE THE PHYSICIAN USED A SNARE CATHETER TO REMOVE THE 1ST MVP-7Q AND TRIED TO COIL THE LESION. HOWEVER, HE WAS ONLY SUCCESSFUL AFTER ADDING AN ADDITIONAL MVP-5Q UPSTREAM, SINCE THE COILS ALONE WOULD NOT BE ABLE TO TERMINATE FLOW. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT EMBOLIZATION WAS PERFORMED USING AN MVP-3Q MICRO VASCULAR PLUG ON THE RIGHT HEPATIC ARTERY AND TWO ADDITIONAL MVP-7QS WERE USED FOR THE LEFT SIDE. THE EMBOLIZATION WAS CARRIED OUT IN COMBINATION WITH AN IMPLANTATION OF A CHEMOTHERAPY PUMP, TO SELECTIVELY TREAT LIVE TUMORS IN A PATIENT WITH A HISTORY OF CANCER. 2 DAYS POST-OP, ONE OF THE MVPS MIGRATED, WHICH RENDERED THE CHEMOTHERAPY PUMP NON-THERAPEUTIC AND NECESSITATED A NEW EMBOLIZATION PROCEDURE. DURING THE REINTERVENTION, THE MIGRATED MVP DEVICE WAS REMOVED, COILS WERE ADDED, AND A NEW MVP-7Q DEVICE WAS IMPLANTED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER PATIENT INJURY REPORTED. ADDITIONAL INFORMATION 23-FEB-2026: THE MVP PLUG WAS SOAKED IN HEPARINIZED SALINE PRIOR TO USE. THE CATHETER WAS FLUSHED BEFORE INSE RTING THE PLUG. A CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. SEVERAL DIFFERENT UNKNOWN SHEATHS HAVE BEEN TRIED UNTIL REACHING TARGET SITE. THE TARGET VESSEL DIAMETER WAS REPORTED AS 5.3MM. IT WAS REPORTED THAT THE ANATOMY WAS DIFFICULT AND TORTUOUS TO REACH TARGET SITE. HOWEVER, LANDING ZONE WAS VERY STRAIGHT. THE PLUG DID FULLY OPEN IN THE TARGET VESSEL BEFORE DETACHING, INCLUDING A 2MIN WAITING TIME BEFORE DETACHING THE PLUG. THE PATIENT WAS IMPLANTED A CHEMOTHERAPY PUMP TO TREAT TUMORS IN HIS LIVER. FOR THE CHEMOTHERAPY TO WORK IN THE LIVER, LIVER ARTERIES WERE EMBOLIZED WITH MVPS TO GUIDE THE CHEMOTHERAPEUTIC AGENT TO THE TARGET SITES. AFTER PLACING THE TUBE OF THE PUMP THROUGH THE A. HEPATICA IN AN ARTERY BRANCH ON THE RIGHT SIDE OF THE LIVER, THE ARTERY WAS CLOSED DISTALLY OF THE TUBE WITH AN MVP-3Q. 2 X MVP-7Q WERE USED ON THE LEFT LIVER ARTERIES TO CLOSE THE INFLOW TO THE LIVER LOBES AND THEREBY INDUCE A FLOW FROM THE RIGHT SIDE OF THE LIVER (INCLUDING THE CHEMOTHERAPEUTIC AGENT). THE PROCEDURE WAS DONE WITH THE GOAL TO INDUCE CHEMOTHERAPY SPECIFICALLY TO THE LIVER, WHICH SHOULD HELP TO REDUCE THE TUMOR SIZE IN THE LIVER AND THEREBY ALLOW A FUTURE RESECTION OF LEFT LIVER PARTS. THE PHYSICIAN MEASURED IN THE CT A VESSEL SIZE OF SLIGHTLY MORE THAN 5MM (ROUGHLY 5.3MM DIAMETER). THIS IS THE REASON WHY THE PHYSICIAN CHOSE AN MVP-7Q FOR THE MEASURED POSITION (1ST MVP-7Q). HE FURTHERMORE ADDED THE 2ND MVP-7Q IN ANOTHER VESSEL A BIT MORE INFERIOR. THE FINAL ANGIOGRAPHY OF THE PROCEDURE INDICATED A SATISFYING RESULT. HOWEVER, THE PHYSICIAN FELT LIKE THE MVP WAS NOT FULLY SEALING THE VESSEL ALREADY THERE. 2 DAYS LATER A REINTERVENTION WAS REQUIRED BECAUSE THE CHEMOTHERAPEUTIC AGENT WOULD NOT REACH THE TARGETED POSITION. THE ANGIOGRAPHY OF THE REINTERVENTION REVEALED A DISTAL MIGRATION OF THE 1ST MVP-7Q. THE 1ST MVP-7Q POSITION BEFORE MIGRATION SEEMED TO BE VERY STRAIGHT, NOT CURVED, AND PROVIDING AN EVEN WALL APPOSITION, ALL BENEFICIAL ASPECTS FOR THE PLACEMENT OF THE MVP IN THAT POSITION. THE ONLY THING THAT POSED A CHALLENGE, WAS AN INCREASED FLOW IN THESE VESSELS. THIS CAN ALSO BE SEEN IN THE REINTERVENTION, WHERE THE PHYSICIAN USED A SNARE CATHETER TO REMOVE THE 1ST MVP-7Q AND TRIED TO COIL THE LESION. HOWEVER, HE WAS ONLY SUCCESSFUL AFTER ADDING AN ADDITIONAL MVP-5Q UPSTREAM, SINCE THE COILS ALONE WOULD NOT BE ABLE TO TERMINATE FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475613 MICROVASCULAR PLUG DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD COVIDIEN 243300293 00763000702106

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Required Intervention