MVP® MVP-5QRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00847536004351), received between Apr 3, 2017 and Jan 7, 2022 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2022Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  PHYSICIAN USED A MICROVASCULAR PLUG (MVP-5Q) DURING PATIENT TREATMENT. IT  IS REPORTED AFTER DEPLOYING THE PLUG DURING THE RETRIEVAL OF THE DELIVERY SYSTEM A PART OF THE PUSHER (MOST DISTAL 2-3CM) DETACHED FROM THE SYSTEM AND WAS LEFT IN THE PATIENT BODY. THE LITTLE DETACHED PART WAS PUSHED INTO THE SPLENIC ARTERY AND LEFT WITHIN THE PATIENT WITH NO PRESERVED ARTERIAL FLOW. NO INJURY REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13190051 ↗
• MalfunctionNov 23, 2020Use of Device Problem; Use of Device Problem

  IT IS REPORTED THAT AN EXPIRED 5Q MICROVASCULAR PLUG WAS IMPLANTED IN A PATIENT. THE DEVICE WAS EXPIRED BY APPROXIMATELY 2 MONTHS WHEN IT WAS IMPLANTED. THERE WAS NO PRODUCT ISSUE REPORTED. NO PATIENT INJURY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10884070 ↗
• MalfunctionJul 28, 2020Difficult to Remove; Detachment of Device or Device Component; Positioning Problem; Migration; Difficult to Remove; Detachment of Device or Device Component; Positioning Problem; Migration

  PHYSICIAN USED A 5Q MICRO VASCULAR PLUG WITH A 0.038 NON-MEDTRONIC CATHETER DURING A PROCEDURE TO TREAT A SOFT TISSUE LESION IN THE PATIENT¿S DISTAL RIGHT HEPATIC ARTERY. MODERATE VESSEL TORTUOSITY IS REPORTED. IT IS REPORTED THAT THE LEFT GASTRIC ARTERY MAY BE CONNECTED TO LEFT HEPATIC ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT IS REPORTED WHEN THE PHYSICIAN TRIED TO DETACH THE PLUG, IT WAS UNSUCCESSFUL. THE PHYSICIAN ATTEMPTED TO USE THE ATTACHED TORQUE AND TRYING TO MANUALLY TWIST OFF THE PLUG WITH A CLAMP SCISSORS, ALSO UNSUCCESSFULLY. THE PHYSICIAN THEN ATTEMPTED TO PULL BACK THE PLUG BUT WAS UNABLE DUE TO RESISTANCE. THE ENTIRE SYSTEM WAS REMOVED, BUT IT WAS OBSERVED ON REMOVAL THAT THE PLUG HAD DETACHED AND REMAINED IN THE PATIENT, HOWEVER IT HAD SHIFTED A BIT (JUMPED). THE PHYSICIAN IS CONCERNED ABOUT OCCLUSION OF THE PATIENT¿S HEPATIC ARTERY. NO FURTHER TREATMENT WAS GIVEN, AND THE PHYSICIAN WILL MONITOR DURING THE NEXT PROCEDURE. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10331214 ↗
• MalfunctionFeb 24, 2020Unintended Ejection; Incomplete or Missing Packaging; Unintended Ejection; Incomplete or Missing Packaging

  MEDTRONIC RECEIVED A REPORT THAT THE MICROVASCULAR PLUG WAS DETACHED IN THE PACKAGE. THE HEALTHCARE PROVIDER (HCP) TRIED TO SCREW IT WITHOUT ANY SUCCESS. THERE WAS NO PATIENT INVOLVEMENT INDICATED WITH THIS EVENT. ANOTHER MICROVASCULAR PLUG OF THE SAME DIAMETER WAS USED FOR THE PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 9743294 ↗
• MalfunctionDec 4, 2019Unintended Ejection; Unintended Ejection

  MEDTRONIC RECEIVED REPORT THAT THE MVP-5Q UNINTENTIONALLY DETACHED WITHIN THE CATHETER. THE PATIENT WAS UNDERGOING EMBOLIZATION OF THE COMMON HEPATIC ARTERY DUE TO A GI BLEED. THE PATIENT'S ANATOMY WAS NOT TORTUOUS. THE MVP SYSTEM PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). A CATHETER FLUSH WAS NOT MAINTAINED DURING THE PROCEDURE. WHEN PUSHING THE DEVICE THROUGH THE MICROCATHETER WITH NO PROBLEMS. IT WAS REPORTED THAT THE DEVICE SUDDENLY COULD NOT BE PUSHED ANY FURTHER. THE DEVICE WAS HALFWAY THROUGH THE CATHETER. THE DEVICE WAS WITHDRAWN AND IT WAS OBSERVED THAT THERE WAS NO PLUG AT THE END OF THE WIRE; THE PLUG WAS STILL IN THE CATHETER. THERE WERE NO REPORTS OF PATIENT INJURY IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9414231 ↗
• MalfunctionJul 29, 2019Unintended Ejection; Physical Resistance/Sticking; Unintended Ejection; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT MICRO VASCULAR PLUG PREMATURELY DETACHED IN THE CATHETER. IT WAS REPORTED THAT THE PHYSICIAN BEGAN TO ADVANCE THE MVP PLUG THROUGH A 4 FRENCH CATHETER. THERE WAS A BIT OF RESISTANCE, SO THE PHYSICIAN FLUSHED THE CATHETER. THE PLUG THEN BEGAN TO ADVANCE THROUGH THE CATHETER AS USUAL. THEN THE PLUG DETACHED IN THE CATHETER SYSTEM. THE TORQUE WAS NOT ON THE WIRE WHEN IT PREMATURELY DETACHED. ANOTHER DEVICE WAS USED AND PROCEDURE COMPLETED. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8836942 ↗
• MalfunctionJan 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED REPORT THAT WHEN THE MVP-5Q PACKAGE WAS OPENED, THE DEVICE WAS NOTED TO BE LOOSE AND DETACHED. THERE WAS NO ALLEGATION THAT THE OUTER OR INNER PACKAGING WAS DAMAGED OR SHOWED EVIDENCE OF TAMPERING. THE CUSTOMER HAS BEEN ADVISED TO RETURN THE DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8274177 ↗
• InjuryMay 14, 2018Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT AN MVP-5Q WAS PLACED IN THE INTERNAL CAROTID (3.5MM) TO STOP BLOOD FLOW (THIS WAS A WORK UP PROCEDURE PRIOR TO TUMOR REMOVAL); HOWEVER, THIS DIDN¿T WORK AND BLOOD FLOW CONTINUED UP THE INTERNAL CAROTID ARTERY. THEN, 5 COILS (TERURMO AZUR HYDROCOILS) WERE PLACED BEHIND THE MVP-5Q AND STILL BLOOD FLOW DID NOT CEASE. AN ADDITIONAL 2 MVP-7Q (1ST MVP PLACED IN VESSEL WITH 5MM DIAMETER AND 2ND MVP IN VESSEL WITH 5.5MM DIAMETER) WERE PLACED PROXIMAL TO THE PREVIOUS PLUG AND COILS AND THE BLOOD STILL FLOWED SLOWLY BUT HAD NOT STOPPED. A FINAL MVP-7Q WAS PLACED WHICH CAUSED THE ARTERY TO OCCLUDE. THE TYPE OF THE TARGET LESION WAS SOFT TISSUE AND THE DEGREE OF CALCIFICATION AND DEGREE OF TORTUOSITY WAS NONE. THERE WAS NO STENOSIS. THERE WERE NO DIFFICULTIES ROTATING THE PUSHWIRE DURING DETACHMENT. THERE WERE NO KNOWN INJURIES REPORTED AS A RESULT OF THE EVENT. THE PLAN WAS FOR THE PATIENT TO GO TO TUMOR REMOVAL THE DAY AFTER THE PROCEDURE, BUT THEY PATIENT REMAINED INTUBATED UNTIL AFTER TUMOR REMOVAL. THE DEVICES WERE SAID TO BE PREPARED ACCORDING TO IFU.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7513003 ↗
• MalfunctionApr 3, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  MEDTRONIC RECEIVED REPORT OF MVP MIGRATION AFTER DETACHMENT. THE PATIENT WAS UNDERGOING MVP-5Q IMPLANTATION IN THE LEFT RENAL ARTERY. THE VESSEL HAD LITTLE TORTUOSITY. ARTERY DIAMETER WAS 3 ¿ 3.5MM. IT WAS REPORTED THAT THE MVP WAS PLACED IN THE LEFT RENAL ARTERY. THERE WERE REPORTEDLY NO ISSUES DURING DELIVERY OR DEPLOYMENT; THE DEVICE WAS NOT REPOSITIONED. A CONTINUOUS FLUSH WAS NOT USED DURING DELIVERY. AFTER PLACEMENT, THERE WAS NO EVIDENCE OF APPROPRIATE WALL APPOSITION. THE MVP WAS DETACHED; CONTRAST WAS INJECTED 15-30 SECONDS LATER. THE CONTRAST WAS INJECTED BY HAND; FLOW RATE WAS APPROXIMATELY 1-2 ML/SEC. IT WAS REPORTED THAT DURING CONTRAST INJECTION, THE MVP MIGRATED DISTALLY. THERE HAD BEEN NO EVIDENCE OF MOVEMENT PRIOR TO CONTRAST INJECTION. AFTER MIGRATION, NO ATTEMPTS WERE MADE TO RETRIEVE THE MVP. THERE WERE NO REPORTS OF PATIENT SYMPTOMS IN CONNECTION WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6455287 ↗