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	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
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.

• 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: 9645055
• Report Number: 3007170829-2020-00002
• Device Sequence Number: 16775919
• Product Code: KRD
• UDI-Device Identifier: 00847536025431
• UDI-Public: 00847536025431
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K150108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/29/2020

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: 01/28/2021
• Device Model Number: MVP-7Q
• Device Catalogue Number: MVP-7Q
• Device Lot Number: A783327
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1