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

Model Number	MVP-5Q
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mvp-5q remains implanted in the patient; product analysis cannot be performed.The reported event is still under investigation; a follow-up mdr will be submitted when investigation is complete.
Event or Problem Description
Medtronic received report of mvp migration after detachment.The patient was undergoing mvp-5q implantation in the left renal artery.The vessel had little tortuosity.Artery diameter was 3 ¿ 3.5mm.It was reported that the mvp was placed in the left renal artery.There were reportedly no issues during delivery or deployment; the device was not repositioned.A continuous flush was not used during delivery.After placement, there was no evidence of appropriate wall apposition.The mvp was detached; contrast was injected 15-30 seconds later.The contrast was injected by hand; flow rate was approximately 1-2 ml/sec.It was reported that during contrast injection, the mvp migrated distally.There had been no evidence of movement prior to contrast injection.After migration, no attempts were made to retrieve the mvp.There were no reports of patient symptoms in connection with this event.
Additional Manufacturer Narrative
The mvp-5q remains implanted in the patient; product analysis cannot be performed.The mvp device will not be returned for analysis as it remains within the patient.Based on the reported information and provided digital video, the report of migration was confirmed.It is likely the lack of continuous flush contributed to the inadequate wall apposition subsequently causing the device to migrate.The diameter of the mvp device is sufficient to allow for full expansion of the implant to the reported diameter of the target vessel (3-3.5mm).All products are 100% inspected for damages and irregularities during manufacture.Per the mvp instructions for use: preparation for use ¿ ¿in order to achieve optimal performance of the mvp system and to reduce the risk of thromboembolic complication, a continuous saline flush should be maintained between microcatheter/ catheter and guidewire and mvp system.¿ if information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Corrected information: sex.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MICROVASCULAR PLUG
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): REVERSE MEDICAL; 13700 alton parkway; irvine CA 92618
• MDR Report Key: 6455287
• Report Number: 3007170829-2017-00002
• Device Sequence Number: 16299049
• Product Code: KRD
• UDI-Device Identifier: 00847536004351
• UDI-Public: 00847536004351
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K141313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2017

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: 05/28/2017
• Device Model Number: MVP-5Q
• Device Lot Number: 15645
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2017
• Supplement Date Received by Manufacturer: 07/07/2017; 07/07/2017
• Initial Report FDA Received Date: 04/03/2017
• Supplement Report FDA Received Date: 07/12/2017; 10/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR