MVP™ MVP-9Q (UDI 00763000702113)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000702113), received between May 13, 2024 and Oct 4, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2024Fracture; Activation, Positioning or Separation Problem; Material Deformation; Fracture; Activation, Positioning or Separation Problem; Material Deformation

  PHYSICIAN ATTEMPTED TO USE A MICROVASCULAR PLUG 9Q WITH A 5FR 5MM NON-MEDTRONIC CATHETER DURING TREATMENT OF A SOFT TISSUE LESION IN THE PATIENTS LEFT MID COMMON ILIAC ARTERY. ARTERY DIAMETER REPORTED AS 8MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THE MVP PLUG WAS SOAKED IN HEPARINIZED SALINE PRIOR TO USE. THE CATHETER WAS FLUSHED BEFORE INSERTING THE PLUG. A CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. IT WAS REPORTED THE MVP WOULD NOT RELEASE. NO RESISTANCE WAS FELT WHEN ADVANCING THE PLUG THROUGH THE INTRODUCER SHEATH OR CATHETER. A BREAK OR KINK WAS NOT OBSERVED ON THE PLUG. THE PLUG WAS RE-SHEATHED INTO THE CATHETER TWICE FOR REPOSITIONING. A STRUT FRACTURE WAS OBSERVED. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. PROCEDURE WAS ABORTED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20367353 ↗
• InjuryMay 13, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  PHYSICIAN IMPLANTED A MICROVASCULAR PLUG 9Q IN THE PATIENTS LEFT INTERNAL ILIAC VEIN ( (B)(6)2024). MODERATE VESSEL TORTUOSITY WAS REPORTED. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED ABRE STENT. THE MVP PLUG WAS SOAKED IN HEPARINIZED SALINE PRIOR TO USE. THE CATHETER WAS FLUSHED BEFORE INSERTING THE PLUG. A CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. TARGET VESSEL DIAMETER REPORTED AS 7-9MM. THE PLUG DID FULLY OPEN IN THE TARGET VESSEL BEFORE DETACHING. PHYSICIAN CONFIRMED SECURE PLACEMENT OF MVP-9Q UNDER FLURO. NO CONTRAST WAS SEEN WHICH CONFIRMED PLUG HAD OPPOSED TO VESSEL WALL. ON AN UNKNOWN DATE POST OP, THE PATIENT WAS ADMITTED TO ER AT A HOSPITAL IN ANOTHER STATE AFTER COMPLAINTS OF CHEST PAIN AFTER PHYSICALLY BENDING OVER TO PICK UP A CHILD. PATIENT FOLLOWED UP WITH ORIGINAL PHYSICIAN WHO PERFORMED THE PROCEDURE. A FOLLOW UP COMPUTED TOMOGRAPHY (CT) SCAN

  Patient problems: Chest Pain; Thrombosis/Thrombus

  MAUDE report 19298543 ↗