MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR 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	08/10/2018
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 a report that the microvascular plug prematurely detached from the pusher wire once unsheathed from the catheter.The plug immediately migrated and had to be retrieved with a snare as a result.There was no further device placed after plug retrieval.There were no related patient symptoms.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The cause of the issue was not determined.It was confirmed that the devices were prepared/flushed as indicated per the ifu.
Additional Manufacturer Narrative
The mvp device (model: mvp-7q lot: 170811) was returned for analysis within a shipping box and within an opened mvp inner pouch.The mvp plug was returned separated from the pushwire.The pushwire and plug were returned within separate plastic bio-pouches.The mvp plug and pushwire were decontaminated as per (b)(4).The mvp plug was found to be separated from the pushwire at the detach zone.The proximal marker band appears to be bent.The proximal end of the proximal marker band was found to be clear of obstruction.Visual inspection of the threaded insert revealed no irregularities.The plug was examined and found to be fully opened.Holes were found with the plug membrane.The pushwire was then examined.No bends or kinks were found with the pushwire.There were five partially filled coil gaps found with the distal threaded section of the pushwire.There does not appear to be any excess solder found with the five partially filled coil gaps which is acceptable as per (b)(4).The distance from the tip of the pushwire to the bus hing thread start was measured to be 0.008" which is within specification (specification per (b)(4).C: 0.010¿ ± 0.002).The plug was re-attached to the distal end of the pushwire.The distal threaded section of the pushwire was completely covered by the plug.Wh ile securing the plug, a torquer was attached to the proximal end of the pushwire.The plug was successfully detached from the pushwire with ~4.5 rotations of the torquer/pushwire.No other anomalies were observed.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): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7818488
• Report Number: 2029214-2018-00746
• Device Sequence Number: 13747036
• Product Code: KRD
• UDI-Device Identifier: 00847536025431
• UDI-Public: 00847536025431
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K150108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/08/2018

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: 03/28/2019
• Device Model Number: MVP-7Q
• Device Catalogue Number: MVP-7Q
• Device Lot Number: 170811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 08/27/2018; 10/16/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 09/10/2018; 11/08/2018
• 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: Required Intervention
• Patient Weight: 5