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

Model Number	QC-7-30-HELIX
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The axium coil (model: qc-7-30-helix lot: a248064) was returned for analysis.The axium pushwire was found broken at ~8.5cm from the proximal end with the release wire pulled for ~6.6mm.The coin was found not against the lumen stop.The axium implant coil was found not attached to the pushwire.The axium implant coil was found detached from the pushwire.The axium implant coil was returned outside of its introducer sheath.The axium implant coil was found damaged and stretched.The detach element was found with the stretched and damaged axium implant coil.No other anomalies were observed.Analysis summary: the axium coil was returned for analysis.The axium pushwire was found broken at ~8.5cm from the proximal end with the release wire pulled for ~6.6mm.The axium implant coil was found not attached to the pushwire.The axium implant coil was found detached from the pushwire.The axium implant coil was returned outside of its introducer sheath.The axium implant coil was found damaged and stretched.The axium implant coil shell weld was found intact.The detach element was found with the stretched and damaged axium implant coil.No damages were found with the detach element.The axium implant coil tip od (outer diameter) and introducer sheath id (inner diameter) were found to be within specifications.Based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ could not be confirmed as the axium implant coil was returned outside of its introducer sheath.There were no reported issue pushing the axium coil out from within the introducer sheath for hydration.Therefore, it is likely that the implant coil became damaged during return of the implant coil back into the introducer sheath during preparation or due to an improper hubbing technique (over tightening of the rhv).Regarding the damage to the pushwire, in this event it is lik ely excessive force (pushing/pulling) was used causing the pushwire to break subsequently detaching the implant coil.Mdrs related to this event: 2029214-2019-00409 2029214-2019-00410.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the coil gave extreme resistance while pushing out the sleeve.The devices were prepared as indicated in the instructions for use (ifu).The coil was returned to medtronic for evaluation and found to be prematurely detached.

• Brand Name: AXIUM HELIX
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8580898
• Report Number: 2029214-2019-00410
• Device Sequence Number: 19297715
• Product Code: KRD
• UDI-Device Identifier: 00836462010178
• UDI-Public: 00836462010178
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/05/2019

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: 03/22/2019
• Device Model Number: QC-7-30-HELIX
• Device Catalogue Number: QC-7-30-HELIX
• Device Lot Number: A248064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 05/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1