MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR AXIUM PGLA 3D; DEVICE, EMBOLIZATION, VASCULAR

Model Number	PC-2-6-3D
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2018
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 coils did not detach.The patient was undergoing a vessel take down surgery to treat a tumor.It was stated that the first coil did not detach.As a result a second coil of the same size and lot number were used which also failed to detach.The healthcare professional (hcp) attempted to detach the coil 4 times with the instant detacher and 2 times with a manual method, with no other instant detacher attempted, but the issue was unresolved.No issue with the instant detacher was noted.There were no related patient symptoms.Additional information received noted that the patient had a normal vessel tortuosity.The patient was ultimately treated with a different coil and are currently in good condition.There was no damage to the pushwire noted once it was removed from the patient, and a continuous flush was administered during the procedure.
Additional Manufacturer Narrative
The axium coil was returned for evaluation inside of a (b)(6) shipping box and with the opened axium coil inner pouch.The axium coil was found to be inside of a biohazard ziploc bag.The instant detacher was not returned.During evaluation, the axium coil was removed from the biohazard ziploc bag.The tack weld replacement (twr) crimps and the pushwire distal to the break indicator at the manual detachment location (via hypotube) were found to be intact.There was an appearance of blood on the pushwire and within the proximal end of the introducer sheath.The implant coil appeared to be damaged and stretched within the introducer sheath.The axium coil could not be pushed out from within the introducer sheath for further evaluation as resistance was encountered.The axium coil was pulled out from within the introducer sheath.The axium implant coil was found to be damaged and stretched with the polypropylene filament intact.An in-house instant detacher was then selected for detachment testing.The axium implant coil successfully detached from the pushwire on the first attempt.All other subassemblies appeared to be normal and no other anomalies were observed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AXIUM PGLA 3D
• 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: 7663642
• Report Number: 2029214-2018-00601
• Device Sequence Number: 1524735
• Product Code: KRD
• UDI-Device Identifier: 00847536014145
• UDI-Public: 00847536014145
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2018

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: 07/05/2019
• Device Model Number: PC-2-6-3D
• Device Catalogue Number: PC-2-6-3D
• Device Lot Number: A304911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2018
• Supplement Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 07/05/2018
• Supplement Report FDA Received Date: 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 32 YR