MVP® MVP-7QRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00847536025431), received between Aug 27, 2018 and Aug 18, 2020 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Migration” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  PHYSICIAN WAS USING MICRO VASCULAR PLUG DURING PROCEDURE TO TREAT A NONE CALCIFIED VESSEL IN THE RIGHT PROXIMAL SPLENIC ARTERY ANEURYSM. THE VESSEL ARTERY IS 5,2MM GOING INTO ANEURYSM AND 6.9 GOING OUT OF THE ANEURYSM. THE DEVICES WERE INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT THE FIRST MVP-7Q WAS OPENED AND SET IN THE VESSEL (6.9MM) BUT DID NOT STOP OR EVEN REDUCE BLOOD FLOW EVEN AFTER MORE THAN 5 MIN. FINALLY NON-MEDTRONIC PUSHABLE COILS WERE ADDED TO STOP FLOW. A 4F NON-MEDTRONIC CATHETER WAS USED. THE SECOND MVP-7Q DEPLOYED IN THE 5.2MM ARTERY GOING INTO THE ANEURYSM. AT FIRST IT SEEMED OPEN BUT THEN IT SUDDENLY DETACHED FROM THE ARTERY AND DRIFTED INTO THE ANEURYSM. FINALLY THE INFLOW WAS EMBOLIZED BY THE NON-MEDTRONIC PUSHABLE COILS. A 4F NON-MEDTRONIC CATHETER WAS USED. THE PLUGS WERE PLACED ON A STRAIGHT SEGMENT AND THERE IS NO EVIDENT REASON WHY THEY WOULD NOT OPEN PROPERLY AND DEPLOY AGAINST THE ARTERY TO STOP FLOW. BOTH PLUGS REMAINS IN THE PATIENT AND CANNOT BE RETRIEVED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 10420479 ↗
• MalfunctionAug 18, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN WAS USING MICRO VASCULAR PLUG DURING PROCEDURE TO TREAT A NONE CALCIFIED VESSEL IN THE RIGHT PROXIMAL SPLENIC ARTERY ANEURYSM. THE VESSEL ARTERY IS 5,2MM GOING INTO ANEURYSM AND 6.9 GOING OUT OF THE ANEURYSM. THE DEVICES WERE INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT THE FIRST MVP-7Q WAS OPENED AND SETIN THE VESSEL (6.9MM) BUT DID NOT STOP OR EVEN REDUCE BLOOD FLOW EVEN AFTER MORE THAN 5 MIN. FINALLY NON-MEDTRONIC PUSHABLE COILS WERE ADDED TO STOP FLOW. A 4F NON-MEDTRONIC CATHETER WAS USED. THE SECOND MVP-7Q DEPLOYED IN THE 5.2MM ARTERY GOING INTO THE ANEURYSM. AT FIRST IT SEEMED OPEN BUT THEN IT SUDDENLY DETACHED FROM THE ARTERY AND DRIFTED INTO THE ANEURYSM. FINALLY THE INFLOW WAS EMBOLIZED BY THE NON-MEDTRONIC PUSHABLE COILS. A 4F NON-MEDTRONIC CATHETER WAS USED. THE PLUGS WERE PLACED ON A STRAIGHT SEGMENT AND THERE IS NO EVIDENT REASON WHY THEY WOULD NOT OPEN PROPERLY AND DEPLOY AGAINST THE ARTERY TO STOP FLOW. BOTH PLUGS REMAINS IN THE PATIENT AND CANNOT BE RETRIEVED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 10420474 ↗
• MalfunctionApr 20, 2020Unintended Ejection; Unintended Ejection

  MEDTRONIC RECEIVED INFORMATION REGARDING A MVP MICRO VASCULAR PLUG THAT DEPLOYED PRIOR TO USE DURING SURGICAL PREP. THE PLUG DEPLOYED DURING PREP. THE COIL WAS TAKEN OUT OF THE WHEEL AND SET IT ON A TABLE. WHEN THEY WENT BACK TO GET THE PLUG OFF OF THE BACK TABLE IT WAS NOTICED THAT THE PLUG WAS DETACHED OFF THE WIRE. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9978006 ↗
• MalfunctionJan 29, 2020Migration; Migration

  MEDTRONIC RECEIVED A REPORT THAT THE MICROVASCULAR PLUG (MVP) MIGRATED UPON RELEASE. THE PATIENT WAS UNDERGOING SURGERY FOR 6MM SPLENIC ARTERY BLEEDING EMBOLIZATION. IT WAS REPORTED THAT THE MVP WAS INSPECTED AND PREPPED WITH NO ISSUES NOTED, THERE WAS NO PRODUCT ISSUE ALLEGED, BUT THE PLUG JUMPED 1-1.5CM AHEAD OF THE TARGETED AREA AS SOON AS IT WAS RELEASED. AS A RESULT, IT OCCLUDES A POLAR ARTERY, AND WAS NOTED THE STATUS WAS IMPLANTED AND REMAINED IN SERVICE. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9645055 ↗
• MalfunctionJan 14, 2020Migration; Migration

  MEDTRONIC RECEIVED INFORMATION THAT THE PLUG MICRO VASCULAR MVP-7Q MIGRATED AFTER PLACEMENT. THE PATIENT WAS BEING TREATED FOR AN ATRIOVENTRICULAR SEPTAL DEFECT. THE PHYSICIAN WAS ATTEMPTING TO REDUCE BLOOD FLOW IN THE PULMONARY ARTERY ,WHICH HAS HISTORICALLY BEEN DONE BY A SURGICAL PROCEDURE. THE PHYSICIAN WAS USING THE MVP (NOT IN ACCORDANCE WITH ITS LABELING) TO TRY TO ACCOMPLISH THE SAME OBJECTIVE ENDOVASCULARLY. PHYSICIAN INTENTIONALLY CREATED A HOLE THROUGH THE DEVICE'S PTFE AND THEN IMPLANTED THE DEVICE INTO THE PULMONARY ARTERY; THE GOAL IS TO REDUCE THE BLOOD FLOW IN THIS VESSEL. THIS IS A HIGH-FLOW SITUATION. DURING FOLLOW-UP LATER, IT WAS DISCOVERED THAT THE MVP HAD MIGRATED (SLIPPED) DISTALLY WITHIN THE SAME VESSEL, BUT THERE WAS NO PATIENT HARM NOTED. IN ORDER TO GET BETTER WALL APPOSITION AND MORE PREDICTABLY REDUCE THE FLOW, THE PHYSICIAN REMOVED THE MVP-7Q ENDOVASCULARLY AND REPLACED IT WITH A NEW MVP-9Q. THE PATIENT WAS NOT BELIEVED TO SUFFER ANY CLINICAL CONSEQUENCES FROM THE MIGRATED DEVICE, AND THE PATIENT IS NOW DOING WELL. THE DEVICE WAS PREPARED PER THE INSTRUCTIONS FOR USE (IFU) BUT WAS NOT USED PER THE IFU. NO PATIENT INJURY OCCURRED. THE VESSEL ANATOMY WAS

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 9588348 ↗
• MalfunctionJul 18, 2019Unintended Ejection; Unintended Ejection

  MEDTRONIC RECEIVED INFORMATION THAT MVP-7Q WAS DETACHED PRIOR TO THE PHYSICIAN INTENTIONALLY DETACHING THE MVP. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8804570 ↗
• MalfunctionJul 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT RESISTANCE WAS FELT AS THE PHYSICIAN ADVANCED THE MEDTRONIC MICROVASCULAR PLUG¿S PUSHWIRE INTO THE GUIDE CATHETER. PRIOR TO THE EVENT, THE PHYSICIAN NOTED THAT THE DEVICE WAS PREPARED AS INDICATED TO THE INSTRUCTIONS FOR USE (IFU) WITHOUT ANY ISSUES. THEN HE STARTED TO LOAD THE DEVICE INTO THE 4FR 65CM GUIDE CATHETER AND BEGAN TO ADVANCE THE PUSHWIRE AND THAT WAS WHEN THE REPORTED EVENT OCCURRED. THE PHYSICIAN REMOVED THE YELLOW INTRODUCER AND PUSHED IT AND ATTEMPTED TO ADVANCE AND REALIZED THAT IT HAD BEEN ALREADY DETACHED WHEN HE WENT TO PULL IT BACK. THE PHYSICIAN TRIED TO REMOVE THE PLUG USING A SNARE, BUT HAD DIFFICULTY DUE TO THE ANGLE OF THE SO HE HAD TO GO UP ARTERIALLY THROUGH THE AORTA. THE PHYSICIAN WAS ABLE TO RECAPTURE AND REMOVE THE DEVICE BY PUSHING AND PULLING IT AT THE SAME TIME. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8784855 ↗
• InjuryAug 27, 2018Migration; Migration

  MEDTRONIC RECEIVED A REPORT THAT THE MICROVASCULAR PLUG PREMATURELY DETACHED FROM THE PUSHER WIRE ONCE UNSHEATHED FROM THE CATHETER. THE PLUG IMMEDIATELY MIGRATED AND HAD TO BE RETRIEVED WITH A SNARE AS A RESULT. THERE WAS NO FURTHER DEVICE PLACED AFTER PLUG RETRIEVAL. THERE WERE NO RELATED PATIENT SYMPTOMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7818488 ↗