MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR MICROVASCULAR PLUG

Model Number	MVP-9Q
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	07/02/2018
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 detached on its own and migrated to a place where there was no harm to the patient.A second plug of the same lot was then used which was noted to have also detached too easily.There were no patient symptoms alleged.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received noted that the causes of the first plug detaching on its own, second plug detaching to easily were unknown.The patient was ultimately trated with a second plug at the target site.There was no tortuosity at the landing zone.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
There was no resistance felt during delivery a continuous flush was used during the case, and there was no bend or torque to the pushwire.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The mvp pushwire (model: mvp-9q; lot: a509896) was returned for analysis within a shipping box; within a sealed tyvek bio-pouch; within two sealed plastic bio-pouches and within an opened mvp inner pouch.The plug will not be returned for analysis as it remains within the patient.The mvp pushwire was decontaminated as per (b)(4).No bends or kinks were found with the pushwire.There were five partial filled coil gaps with the pushwire distal threaded section.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 bushing thread start was measured to be 0.009¿ which is within specification (specification 0.010¿ ± 0.002).The mvp plug was found to be separated from the pushwire at the detach zone.No other anomalies were observed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MICROVASCULAR PLUG
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7689703
• Report Number: 2029214-2018-00617
• Device Sequence Number: 600545
• Product Code: KRD
• UDI-Device Identifier: 00847536027732
• UDI-Public: 00847536027732
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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,Followup,Followup
• Report Date (Section B): 10/26/2018

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: 07/28/2019
• Device Model Number: MVP-9Q
• Device Catalogue Number: MVP-9Q
• Device Lot Number: A509896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 07/13/2018; 08/09/2018; 08/08/2018; 10/26/2018
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 08/07/2018; 08/31/2018; 10/03/2018; 10/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 60