MVP® MVP-9QRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00847536027732), received between Jul 16, 2018 and Oct 27, 2021 — classified as 4 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (8 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  PHYSICIAN WAS ATTEMPTING TO USE MICROVASCULAR PLUG TO TREAT A PATIENT. 5 FR MPA CATHETER USED. TARGET VESSEL DIAMETER 7.24 ¿ 8.5 MM. MINIMAL LESION TORTUOSITY. MVP PLUG SOAKED IN HEPARINISED SALINE PRIOR TO USE. CATHETER FLUSHED BEFORE INSERTING THE PLUG. CONTINUOUS FLUSH NOT MAINTAINED DURING THE PROCEDURE. IT WAS REPORTED THAT THE PLUG MOVED FROM DISTALLY DEPLOYMENT ZONE AFTER DEPLOYMENT. THE DOCTOR SUSPECTED THE PLUG MAY NOT BE FULLY OPENED SO THE PLUG MOVED AFTER DEPLOYMENT. PHYSICIAN THOUGHT THE PLUG DIDN¿T FULLY OPEN IN THE TARGET VESSEL BEFORE DETACHING. THE DOCTOR HAS DONE POST-OP CT AND FOUND THE PLUG IS OPENED. THE PATIENT IS FINE WITHOUT ANY INJURY. THE PLUG IS REMAINED IMPLANTED. THE PROCEDURE WAS COMPLETED BY REPLACING WITH NON-MEDTRONIC PLUG. NO PATIENT INJURY REPORTED. PATIENT IS FINE AND NO FURTHER TREATMENT REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12702752 ↗
• MalfunctionOct 11, 2021Fracture; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Positioning Problem; Fracture; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Positioning Problem

  PHYSICIAN WAS ATTEMPTING TO USE A MICROVASCULAR PLUG DURING TREATMENT OF A PATIENT. IT WAS REPORTED PHYSICIAN PLACED THE MVP IN THE VESSEL AND COULD NOT RELEASE IT. MVP WAS NOT TURNING WHEN HE WAS TURNING THE PUSHER WIRE TO RELEASE IT. AFTER A WHILE THE PUSHER WIRE HAD A SHAPE LIKE A CLOT AND THE HCP COULD NOT RELEASE THE MVP AND COULD NOT PULL IT BACK IN THE CATHETER 5FR 0.038. PHYSICIAN PULLED A BIT STRONGLY THE PUSHER WIRE AND THE PUSHER WIRE BROKE. THE PHYSICIAN DID A CT SCAN 4 DAYS LATER, AS HE WAS SUSPECTING THAT A PART OF THE PUSHER WIRE WAS STILL ATTACHED TO THE MVP. THE PATIENT IS VERY FINE AND THE PHYSICIAN CONFIRMED THAT THERE IS STILL A BIT OF PUSHER WIRE ATTACHED TO THE MVP. THE PHYSICIAN HAS DECIDED TO DO NOTHING ELSE AT THE MOMENT AND AT THIS STAGE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12604449 ↗
• InjurySep 27, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  PHYSICIAN WAS ATTEMPTING TO USE A MICROVASCULAR PLUG DURING TREATMENT OF A PATIENT. IT WAS REPORTED THAT THIS MVP-9Q WAS PREPPED, DELIVERED AND DEPLOYED CORRECTLY. ACCESSED RADIAL ARTERY. THEN A NON-MEDTRONIC COIL 10MM X 19MM WAS DEPLOYED IN A RADIAL VEIN. THEN BECAUSE FLOW WAS STILL BRISK A MVP-9Q WAS PLACED IN THE SAME RADIAL VEIN BEHIND THE COIL. ALTHOUGH THE MVP APPEARED TO BE ADVANCED INTO THE PROXIMAL END OF THE COIL, IT WAS THEN PULLED BACK AND POSITIONED ABOUT 10MM PROXIMAL TO THE COIL. BOTH COIL AND MVP WERE DEPLOYED AND SITTING STILL BUT FLOW STILL VISIBLE. AT THAT POINT DOCTOR DECIDED FOLLOWING A BOLUS OF DIE AND SALINE MIX SINCE THE FISTULA WAS MUCH MORE PATIENT THEY WOULD MOVE ON TO BALLOONING THE FISTULA PART OF THE PROCEDURE. ONCE THE WIRE WAS POSITIONED ACROSS THE FISTULA THEY GAVE ANOTHER BOLUS OF DIE AND SALINE MIX AND DISCOVERED BOTH THE COIL AND MVP HAD MIGRATED UP TO WHAT LOOKED TO BE THE BRACHIAL VEIN. FROM THERE A SNARE WAS USED TO SLIDE BY THE MIGRATED MVP AND COIL. FROM THERE IT WAS DECIDED SINCE THE MVP AND COIL APPEARED TO BE STABLE WITH THE SNARE DISTAL AND INTERTWINED, THEY WOULD CALL FOR AMBULANCE TRANSPORT OF PATIENT TO ANOTHER HOSPITAL TO THEIR CARDI

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12532077 ↗
• MalfunctionMay 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A MICROVASCULAR PLUG WITH A 5FR SHEATH AND 0.038 CATHETER DURING A PATIENT PROCEDURE. IT IS REPORTED THAT WHILE PUSHING THE MVP 9 THROUGH THE 5FR .038 CATHETER THE MVP DETACHED IN THE CATHETER. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11796337 ↗
• MalfunctionFeb 23, 2021Migration or Expulsion of Device; Activation, Positioning or Separation Problem; Migration or Expulsion of Device; Activation, Positioning or Separation Problem

  PHYSICIAN WAS ATTEMPTING TO USE MICROVASCULAR PLUG DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE PROXIMAL COMMON ILIAC ARTERY. THE DEVICE WAS INSPECTED WITH ISSUES NOTED. DEVICE WOULD NOT EXPAND ANYMORE. THE DEVICE WAS PREPPED PER IFU WITH ISSUES IDENTIFIED. IT WAS REPORTED THAT THE MVP WAS INTENDED TO USE TO EMBOLIZE A HYPO GASTRIC ARTERY. THE MVP WAS PUT IN THE HYPO GASTRIC ARTERY THROUGH A NON-MEDTRONIC 5FR 65CM SHEATH AND 0.038" ANGIOGRAPHIC CATHETER (2 SIDE HOLES). AFTER PLACEMENT, THE CATHETER INCLUDING THE MVP DISLOCATED DUE TO TENSION IN THE SYSTEM (RETROGRADE APPROACH). THE MVP WAS RETRIEVED AND THEN FOUND OUT THAT THE MVP WOULD NOT EXPAND ANYMORE TO ITS ACTUAL SIZE. PHYSICIAN REPLACED IT WITH A NEW PRODUCT AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11363915 ↗
• 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 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 11320598 ↗
• InjuryJan 28, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  PHYSICIAN USED A 9Q MICRO VASCULAR PLUG DURING PATIENT TREATMENT. THE PHYSICIAN EMBOLIZED THE LEFT KIDNEY DUE TO TRAUMA. THE PHYSICIAN INTIIALLY INJECTED EMBOSPHERES TO EMBOLISE THE SMALL VESSELS THEN PLACED THE MVP-9Q IN A 7MM MAIN RENAL ARTERY. THE PHYSICIAN DETACHED THE PLUG AND INJECTED CONTRAST TO CHECK THE PLACEMENT OF THE PLUG. AS THE PHYSICIAN WITHDREW THE CATHETER IT WAS OBSERVED THE PLUG MOVED AND FLOWED DOWN THE AORTA EVENTUALLY STOPPING IN THE LEFT PROFUNDA ARTERY. THE PLUG WAS RETRIEVED USING A GOOSENECK SNARE SAFELY. NO FURTHER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11242960 ↗
• InjurySep 4, 2020Migration or Expulsion of Device; Activation, Positioning or Separation Problem; Migration or Expulsion of Device; Activation, Positioning or Separation Problem

  PHYSICIAN WAS ATTEMPTING TO USE MVP-9Q MICRO VASCULAR PLUG 9Q DURING PROCEDURE TO TREAT NON- CALCIFIED SOFT TISSUE LESION IN MID PORTAL LIVER VEIN WITH NO STENOSIS. THE DEVICE WAS INSPECTED WITH ISSUE NOTED, THE DEVICE DID NOT EXPAND AFTER SHEATH WAS RETRACTED AND EMBOLIZED DISMALLY TO A SIDE BRANCH. A SECOND MICRO VASCULAR WAS ATTEMPTED TO BE USED AND IT DID NOT EXPAND. IT WAS REPORTED THAT THIS DEVICE WAS ROTATING WHILE DEPLOYMENT ATTEMPT AND WAS REMOVE FOR INSPECTION. THIS DEVICE WAS REMOVED FROM THE PATIENT WITHIN THE SHEATH. THERE WAS NO FURTHER INJURY REPORTED.

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

  MAUDE report 10493162 ↗
• MalfunctionJul 28, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN USED A 9Q MICRO VASCULAR PLUG WITH A NON-MEDTRONIC 4FR SHEATH DURING A PROCEDURE TO TREAT THE PATIENT¿S PROXIMAL LEFT INTERNAL ILIAC ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT IS REPORTED THE PLUG PRE-DETACHED IN THE 4FR SHEATH. THE DETACHMENT OCCURRED FULLY IN THE SHEATH. NO PART OF THE DEVICE REMAINED IN THE PATIENT. A SECOND 9Q MICRO VASCULAR PLUG WAS OPENED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10331200 ↗
• MalfunctionNov 25, 2019Unintended Ejection; Unintended Ejection

  MEDTRONIC RECEIVED A REPORT OF MVP-9Q UNINTENTIONAL DETACHMENT IMMEDIATELY AFTER BEING PUSHED OUT OF THE CATHETER. THIS EVENT OCCURRED DURING THE TREATMENT OF AN INTERNAL ILIAC VESSEL. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE VESSEL SIZE WAS 7MM, THE CUSTOMER WORKED CROSS-OVER. THE DEVICE WAS PREPPED PER IFU BUT CONTINUOUS FLUSH WAS NOT USED. THE PUSHWIRE WAS NOT INTENTIONALLY ROTATED WHEN THE EVENT OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9373814 ↗
• MalfunctionNov 25, 2019Unintended Ejection; Unintended Ejection

  MEDTRONIC RECEIVED A REPORT OF MVP-9Q UNINTENTIONAL DETACHMENT IMMEDIATELY AFTER BEING PUSHED OUT OF THE CATHETER. THIS EVENT OCCURRED DURING THE TREATMENT OF AN INTERNAL ILIAC VESSEL. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE VESSEL SIZE WAS 7MM, THE CUSTOMER WORKED CROSS-OVER. THE DEVICE WAS PREPPED PER IFU BUT CONTINUOUS FLUSH WAS NOT USED. THE PUSHWIRE WAS NOT INTENTIONALLY ROTATED WHEN THE EVENT OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9373813 ↗
• MalfunctionApr 19, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PLUGS COULD NOT OPEN IN THE VESSEL. IT WAS NOTED THAT THE PATIENT'S VESSEL DIAMETER WAS 6MM. THERE WERE NO RELATED PATIENT SYMPTOMS. THE DEVICES WERE PREPARED AND FLUSHED AS INDICATED PER THE IFU. THE VESSEL WAS MODERATELY TORTUOUS. USED COMPETITOR¿S MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8532003 ↗
• MalfunctionApr 9, 2019Migration; Migration

  IT WAS NOTED THAT THE PHYSICIAN DID 3 SMALL HAND PUFFS OF CONTRAST AROUND THE PLUG TO CHECK PLACEMENT AND DETACHED WITHIN 60-90 SECONDS, AT WHICH POINT THERE WAS LITTLE TO NO CESSATION OF FLOW UPON IMMEDIATE DETACHMENT. THEY WATCHED THE PLUG AND WITHIN A MINUTE IT MIGRATED FURTHER DISTAL DOWN THE VESSEL AND LODGED AGAINST A CURVE BUT WAS NOT OCCLUSIVE AT ALL. AT THE 10 MINUTE MARK AFTER MIGRATION THE PLUG MIGRATED AROUND A CURVE LANDING FURTHER IN THE VESSEL AND WAS STILL NOT OCCLUSIVE. IT IS UNKNOWN IF THERE WERE ANY RELATED PATIENT SYMPTOMS. THE DEVICES WERE FLUSHED PER THE IFU. IT WAS NOTED THAT THE SPLENIC ARTERY WAS MEASURED TO BE 7.2MM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8495221 ↗
• MalfunctionJan 24, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PLUG WASN'T ABLE TO LOAD INTO THE CATHETER CAUSING AN INABILITY TO ADVANCE. THERE WERE NO RELATED PATIENT SYMPTOMS. THE DEVICES FLUSHED/PREPARED AS INDICATED PER THE IFU. ANATOMY WAS NOT TORTUOUS. YES, THERE WAS DAMAGE TO THE MVP, WE BELIEVE THIS TO BE THE CAUSE OF THE ISSUE. WE BELIEVE THIS HAPPENED LOADING THE MVP INTO THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8276131 ↗
• InjuryDec 17, 2018Migration; Migration

  MEDTRONIC RECEIVED REPORT THAT THE MVP-9Q MIGRATED AFTER BEING IMPLANTED IN THE SPLENIC ARTERY. THE MVP-9Q WAS IMPLANTED IN THE SPLENIC ARTERY WITH NO NOTICEABLE ISSUES. THE VESSEL MEASURED 7MM. A MVP-7Q WAS PLACED IN THE COMMON HEPATIC ARTERY AND COILS WERE PLACED IN THE CELIAC ANEURYSM AS WELL AS A FEEDING GASTRIC VESSEL. NO MOVEMENT OF THE MVP-9Q WAS NOTICED UNIT THE SHEATH WAS REMOVED FROM THE CELIAC TRUNK THEN THE MVP-9Q MOVED CONSIDERABLY DISTALLY. NO SYMPTOMS HAVE BEEN NOTICED WITH THE PATIENT YET BUT IT IS EXPECTED THAT THE PATIENT WILL EXPERIENCE A PARTIAL OR FULL SPLENIC INFARCT. HOWEVER, AS OF NOW THE PATIENT IS ASYMPTOMATIC. THIS EVENT OCCURRED DURING THE TREATMENT OF A CELIAC TRUNK ARTERY ANEURYSM TREATMENT.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 8169212 ↗
• MalfunctionJul 16, 2018Migration or Expulsion of Device; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE MICROVASCULAR PLUG DETACHED ON ITS OWN AND MIGRATED TO A PLACE WHERE THERE WAS NO HARM TO THE PATIENT. A SECOND PLUG OF THE SAME LOT WAS THEN USED WHICH WAS NOTED TO HAVE ALSO DETACHED TOO EASILY. THERE WERE NO PATIENT SYMPTOMS ALLEGED.

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

  MAUDE report 7689703 ↗
• MalfunctionJul 16, 2018Migration or Expulsion of Device; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE MICROVASCULAR PLUG DETACHED ON ITS OWN AND MIGRATED TO A PLACE WHERE THERE WAS NO HARM TO THE PATIENT. A SECOND PLUG OF THE SAME LOT WAS THEN USED WHICH WAS NOTED TO HAVE ALSO DETACHED TOO EASILY. THERE WERE NO PATIENT SYMPTOMS ALLEGED.

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

  MAUDE report 7689687 ↗