MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CONCERTO NYLON; DEVICE, EMBOLIZATION, VASCULAR

Model Number	NV-7-30-HELIX
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices were not returned for analysis.Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.Linked with mdr: 2029214-2019-00951.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that the 2 concerto coil migrated and required intervention.During the completing of an embolization of a varicocele.The varicocele was treated with a combination of coils and sclerosant.A concerto 4x10 was placed, followed by 7x30, injected sclerosant then went to cap the top of the gonadal below the renal origin with a 7x30 and embedded a 4x10 to create a dense pack at the top.The initial visual result looked good.A slight puff of contrast was performed and looked good.The catheter was back to do a more powerful injection as a final run.Upon injecting, the last 2 coils shot up and out of the gonadal vein flowing into the renal vein.The 4x10 coil sat at the renal origin off of the inferior vena cava (ivc) for a moment and then shot up to the lungs.The 7x30 was strung out and hanging half in the gonadal and half in the renal.The concerto coil 7x30 was snared out quickly.Attempts were made to snare the 4x10 concerto coil out of the lung.An hour plus without success.The varicocele embolization was then completed with 7x30 (a541620).Then attempts to remove the 4x10 coil from the lung were resumed.Variety of techniques were used and finally was able to pull the coil out of the lung.These coils were initially deployed and detached in the appropriate location (gonadal vein) and then migrated out to renal and lung.The devices were prepared and used per the instructions for use (ifu).The reported event caused the procedure to extend for an additional 2.5 hours while removing the coil from the lungs.No symptoms at the time of the report.A follow up scan of the lung will be performed in a month.The vessel anatomy and blood flow were both normal.Ancillary device: boston sci renegade stc.

• Brand Name: CONCERTO NYLON
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9119471
• Report Number: 2029214-2019-00952
• Device Sequence Number: 2384027
• Product Code: KRD
• UDI-Device Identifier: 00847536033580
• UDI-Public: 00847536033580
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K090046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2019

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: 07/08/2022
• Device Model Number: NV-7-30-HELIX
• Device Lot Number: A861158
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2019
• Initial Report FDA Received Date: 09/25/2019
• 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 Age: 19 YR