MAUDE Adverse Event Report: REVERSE MEDICAL MICROVASCULAR PLUG; DEVICE, EMBOLIZATION, VASCULAR

Model Number	MVP-7Q
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	11/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the reported information, it is likely that the manipulation of the ptfe cover contributed to the reported event of migration.However, since the device was not returned, we are unable to perform further root cause analysis and the exact cause of the reported event is unknown.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.No corrective action.Monitoring and trending this type of event.Per the instructions for use (ifu), indications for use: the reverse medical corporation mvp® micro vascular plug system is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
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 slight in tortuosity.The physician notes that the device was not designed for this application, and he does not consider it a defective device.The mvp was being used in an off-label manner to treat this patient with an atrioventricular septal defect.Device was implanted in the pulmonary artery and removed.This was a procedure to treat an atrioventricular septal defect by reducing the flow into the heart.This device was placed into the pulmonary artery, in a high-flow situation.Weight: (b)(6) kg.Two mvp-7 were implanted on (b)(6) 2019, one in the lpa and one in the rpa.The mvp 7 implanted in the rpa migrated to the pa, the mvp 7 implanted in the lpa was fine.

• Brand Name: MICROVASCULAR PLUG
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): REVERSE MEDICAL; 13700 alton parkway, ste. 167; irvine CA 92618
• MDR Report Key: 9588348
• Report Number: 3007170829-2020-00001
• Device Sequence Number: 14318084
• Product Code: KRD
• UDI-Device Identifier: 00847536025431
• UDI-Public: 00847536025431
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K150108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2021
• Device Model Number: MVP-7Q
• Device Lot Number: A906777
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 01/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 DA
• Patient Weight: 5