MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM PGLA HLX; DEVICE, EMBOLIZATION, VASCULAR

Model Number	PC-2-8-HELIX
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis #254727491:equipment used: vis (m-77148), 203cm ruler (m-83360), pin gauge sets (m-84080, m-84082) analysis finding: the axium coil (model: pc-2-8-helix lot: a937052) was returned for analysis within a shipping box; within a resealable biohazard pouch; within an opened axium inner pouch; without a dispenser coil and without an introducer sheath.The axium coil was decontaminated as per the manufacturer policy.The axium pusher was found bent at ~6.1m from the proximal end and found kinked at ~35.2cm from the distal end.The coin was found against the lumen stop; the shield coil was found damaged and the axium implant coil was found damaged, stretched and broken from the pusher with the polypropylene filament also broken.The axium implant coil could be tested for resistance due to the damages found on the device and the introducer sheath was not returned for analysis.The axium implant coil tip od (outer diameter) was measured and found to be 0.0110¿ which is within specification (0.0112¿ +.001/-.002).The introducer inner diameter could not be measured and any conformation to specification or contribution to the resistance could not be assessed.No other anomalies were observed.Based on the device analysis and reported information, t he customer¿s report of ¿coil resistance/stuck in sheath¿ could not be confirmed.The axium pusher was found bent/kinked and the implant coil was found damaged/stretched/broken.There were no reported issues pushing the concerto implant coil from within the introducer sheath during preparation per ifu.Therefore, it is possible the implant coil became damaged when retracting the implant coil following hydration or due to improper hubbing technique (over tightening of the rhv) subsequently causing the implant coil to become stuck.Advancing the coil against resistance would result in damage to the implant coil and kinks to the pusher.No non-conformances were found to specification that would contribute towards the resistance.There is no indication that the event is related to a manufacturing issue and all devices are 100% inspected for damage and irregularities during the manufacturing process.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that there was resistance in the sheath with the axium coils.The coil would not advance into the catheter and was replaced.The patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).Ancillary devices include a non-medtronic microcatheter.

• Brand Name: AXIUM PGLA HLX
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10507245
• Report Number: 2029214-2020-00909
• Device Sequence Number: 19150027
• Product Code: KRD
• UDI-Device Identifier: 00847536032989
• UDI-Public: 00847536032989
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K081465
• 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
• Report Date (Section B): 09/09/2020

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: 11/21/2022
• Device Model Number: PC-2-8-HELIX
• Device Catalogue Number: PC-2-8-HELIX
• Device Lot Number: A937052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2020
• Initial Report FDA Received Date: 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR