MVP™ MVP-9Q (UDI 00763000307776)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000307776), received between Dec 1, 2020 and Apr 14, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2021Migration or Expulsion of Device; Activation, Positioning or Separation Problem; Migration or Expulsion of Device; Activation, Positioning or Separation Problem

  MICROVASCULAR PLUGS 9Q (MVP-9Q) WERE USED TO CREATE AN ANIMAL MODEL DURING AN ANIMAL STUDY. DURING PROCEDURE, 2 MVPS WERE USED AND DEPLOYED IN A PORCINE CLOT MODEL, AND THE MVPS WERE USED TO BLOCK VENOUS FLOW FROM SIDE BRANCHES. IT WAS REPORTED THAT ONE OF THE MVPS DID NOT APPEAR TO FULLY EXPAND. WE DID NOT NOTICE THIS WHEN WE IMPLANTED MVP, BUT LATER ON NECROPSY, WE SAW THAT IT HAD MIGRATED TO THE LUNG AND DID NOT APPEAR TO BE FULLY EXPANDED. DURING INVESTIGATION OF THE VENOGRAPHIC IMAGES, AND IN HINDSIGHT IT DOES NOT APPEAR TO BE FULLY EXPANDED EVEN ON DAY OF IMPLANT. THIS WAS NOT TYPICAL USE FOR THE MVP AND NOT PER IFU (IN AN ANIMAL AND BLOCKING VENOUS FLOW). A NON-MEDTRONIC 5FR CATHETER WAS USED. DIMENSIONS OF THE VESSEL PLUGGED WITH THE MVP UNKNOWN, BUT IT WAS A LARGE MEDIAL PELVIC TRIBUTARY ORIGINATING FROM THE EXTERNAL ILIAC VEIN. THE EXTERNAL ILIAC DIAMETER WAS 14.0MM (MAJOR), 9.6MM (MINOR). TEN DAYS LAT ER WHEN NOTICED, MVP WAS EXPLANTED. THE MVP WAS INTENDED TO BE USED TO BLOCK VEIN BRANCHES IN ORDER TO CREATE STASIS FOR DVT CLOT FORMATION AND AS SUCH WAS NOT USED PER THE IFU.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11665044 ↗
• MalfunctionFeb 12, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  THE PROCEDURE IS A SPLENIC ANEURYSM'S EMBOLIZATION WITH ENDOVASCULAR LIGATURE TECHNIQUE USING MICRO VASCULAR PLUG (MVP). THE PHYSICIAN WANTED TO OCCLUDE THE VESSEL BEFORE AND AFTER THE ANEURYSM IN ORDER TO ISOLATE IT AND DECIDED TO EMBOLIZE THE PROXIMAL PART OF THE SPLENIC ARTERY WITH MVP-9Q BECAUSE THE VESSEL SIZE AT CT WAS 7-8 MM. PHYSICIAN POSITIONED THE MVP AND STARTED TO CREATE A CAST WITH SOME COILS BUT AFTER SOME MINUTES THE MVP MOVED WITH THE COILS INSIDE THE ANEURYSM. PHYSICIAN REPEATED THE PROCEDURE A SECOND TIME BUT THE RESULT WAS THE SAME, MVP MOVED FORWARD INSIDE THE ANEURYSM. THE PROCEDURE WAS CONCLUDED CHANGING CATHETER AND POSITIONING A NON-MEDTRONIC PLUG (AMPLATZER PLUG II) WITH A DIAMETER OF 16 MM. THERE WAS NO PATIENT INJURY OR VESSEL DAMAGE AS A RESULT OF THE MICRO PLUG MIGRATION. NO FURTHER INTERVENTION WAS NECESSARY DUE TO THE MICRO PLUG MIGRATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11320610 ↗
• MalfunctionDec 1, 2020Detachment of Device or Device Component; Device Damaged by Another Device; Difficult to Advance; Physical Resistance/Sticking; Detachment of Device or Device Component; Device Damaged by Another Device; Difficult to Advance; Physical Resistance/Sticking

  A PHYSICIAN WAS ATTEMPTING TO USE A MICRO VASCULAR PLUG DEVICE TO TREAT A PATIENT. THE PHYSICIAN HAD GAINED ACCESS INTO THE RIGHT INTERNAL ILIAC ARTERY USING A NON-MEDTRONIC SHEATH, AND THEN USED A NON-MEDTRONIC 5FR .038" ID TO ACCESS THE AVM. THE PHYSICIAN PREPPED THE MVP-9Q PER THE IFU, LOADED THE PLUG INTO THE CATHETER WITH NO ISSUES. TECH ASSISTING THE DOC NOTICED QUITE A BIT OF RESISTANCE WHILE DELIVERING THE PLUG TO THE TREATMENT AREA. PLUG WAS ABOUT 2-3CM AWAY FROM BEING DEPLOYED INTO THE AVM FEEDING VESSEL BUT WOULD NOT ADVANCE PAST THIS POINT. PHYSICIAN THEN RE-SHEATHED MVP PLUG BACK INTO THE YELLOW LOADING SHEATH, FLUSHED THE CATHETER AGAIN, AND TRIED TO ADVANCE THE PLUG BACK INTO THE 5FR CATHETER BUT THE PLUG WAS STUCK. IT THEN LOOKED LIKE THE WIRE ATTACHED TO THE PLUG HAD DETACHED AND POKED A HOLE IN THE YELLOW LOADING SHEATH. WE SEARCHED THE BODY TO MAKE SURE THE PLUG HAD NOT DETACHED INSIDE THE 5FR CATHETER, AND FINALLY FOUND THE PLUG INSIDE THE YELLOW LOADING SHEATH. THE WIRE HAD BECOME DETACHED FROM THE PLUG AT THE DETACHMENT ZONE. WE PROCEEDED TO LOAD ANOTHER MVP-9Q IN THE SAME 5FR CATHETER, AND HAD NO ISSUES DURING DELIVERY OR DEPLOYMENT. PATIENT WAS BEING TREATED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10926836 ↗