MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM 3D; DEVICE, EMBOLIZATION, VASCULAR

Model Number	QC-2-6-3D
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The axium coil (model: qc-2-6-3d lot: a616716) was returned for analysis within a shipping box; within an open axium outer carton; without a dispenser coil and within an introducer sheath.No damages or irregularities were found with the axium pushwire.The introducer sheath was found correctly assembled on the pushwire with the wavelock at the proximal end.The introducer sheath was bent/wavy from ~82.6cm to ~89.0cm from the proximal end.The axium implant coil was found within the introducer sheath to be already detached from the pushwire.The implant coil was found to be damaged within introducer sheath.The pushwire was pulled out from within the introducer sheath and the implant coil was flushed out of the introducer sheath using water for further analysis.The coin was found pushed up against the lumen stop with the shield coil intact.The detach element ball and stick was still attached to the pushwire, however the detach element loop was broken off, causing the implant coil to become detached.The axium implant coil tip od (outer diameter) was measured and found to be 0.0115¿ which is within specification (specification: 0.0112¿ +.001/-.002).The introducer sheath id (inner diameter) was measured and found to be 0.0195¿ (0.4953mm) which is within specification (specification: 0.47mm +0.03/-0.00).No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿coil r esistance/stuck in sheath¿ was confirmed.The axium implant coil was found damaged within the introducer sheath.Customer reported there were no issues pushing the axium implant coil from within the introducer sheath during preparation per ifu and there were no kinks/damages with implant coil during hydration/inspection.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.The detach element was found broken at the loop.It is likely that this damage occurred when trying to retract the implant coil against the reported resistance.The introducer sheath was found bent/wavy; however, the cause could not be determined.It is possible that this damage occurred either due to manipulation against the reported resistance or during return shipping to medtronic for analysis.There was no non-conformance to specification identified that led to the event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that upon prep and advancement of the coil, sheath friction was observed, there were not able to push or transfer the coil into the microcatheter.The coil was inspected and could not be advanced through the sheath on the bench.The coil was hydrated per the ifu.There was no kink/damage to the coil.The introducer sheath was held vertically when the implant coil was pulled back inside during hydration.The patient was ultimately treated with another manufacturer's coils.The patient was being treated for neurovascular abnormalities, and the grade type was fistula.There were no patient symptoms associated with the event.The devices were prepared as indicated in the ifu.Ancillary device: neuron max sheath, sl10 microcatheter.

• Brand Name: AXIUM 3D
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8931196
• Report Number: 2029214-2019-00872
• Device Sequence Number: 216593
• Product Code: KRD
• UDI-Device Identifier: 00847536017436
• UDI-Public: 00847536017436
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133310
• 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
• Report Date (Section B): 08/26/2019

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: 03/20/2021
• Device Model Number: QC-2-6-3D
• Device Catalogue Number: QC-2-6-3D
• Device Lot Number: A616716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1