MAUDE Adverse Event Report: MEDTRONIC NEUROVASCULAR MICROVASCULAR PLUG; DEVICE, EMBOLIZATION, VASCULAR

Model Number	MVP-9Q
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	11/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
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.

• Brand Name: MICROVASCULAR PLUG
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MEDTRONIC NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8169212
• Report Number: 2029214-2018-01074
• Device Sequence Number: 13792729
• Product Code: KRD
• UDI-Device Identifier: 00847536027732
• UDI-Public: 00847536027732
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K150108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2019
• Device Model Number: MVP-9Q
• Device Catalogue Number: MVP-9Q
• Device Lot Number: A482015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR