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

Model Number	QC-2-6-3D
Medical Device Problem Codes	Stretched (1601); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The axium coil (model: qc-2-6-3d lot: a261070) was returned for analysis within the introducer sheath.The axium coil was found to be inverted within the introducer sheath with the wavelock at the distal end.Blood was present within the introducer sheath.The axium pushwire was found to be broken at ~73.0cm from proximal end, and retained by release wire.The axium implant coil was found to be damaged within the introducer sheath.No damages or irregularities were found with the introducer sheath.The axium coil was not able to be pushed out from within the introducer sheath due to resistance.The axium implant coil tip od (outer diameter) was found to be 0.0110¿ which is within specifications (specifications: 0.0112¿ +0.001¿ / -0.002¿).The id (inner diameter) of the introducer sheath was found to be 0.0190" (0.4826mm), which is within specifications (specifications: 0.47mm +0.03/ -0.00).No other anomalies were observed.Based on the device analysis, and the reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ was confirmed.However, the customer¿s report of ¿coil stretch¿ could not be confirmed.As there were no issues reported deploying the axium coil prior to use, it is possible that the implant coil became damaged during preparation, or due to improper hubbing technique (over tightening of the rhv) subsequently becoming stuck during deployment.However, as there was an appearance of blood within the introducer sheath under tightening of the rhv can lead to blood back flow, and to difficulty during delivery subsequently damaging the implant coil.Regarding the damage to the axium pushwire, as the issue was not reported by the customer, it is possible the damage occurred during return to medtronic for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during the coiling treatment of unruptured, saccular, right internal carotid artery aneurysm, this coil stuck inside the introducer sheath.It was reported that during introduction of the spring, there was a roughness in the sheath (application introducer) of the spring making the spring out of the way.There was no decoupling of the spiral from the tip of the implant introducer.Preventing the continuity of the procedure.The patient¿s blood flow was normal.No patient injury was reported.The coil was hydrated per the ifu.Different sizes of coils were used and patient treated.Coil was removed for evaluation, and was found to be stretched in its proximal third.

• 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: 10604253
• Report Number: 2029214-2020-00956
• Device Sequence Number: 372707
• Product Code: KRD
• UDI-Device Identifier: 00847536017436
• UDI-Public: 00847536017436
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 09/29/2020

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: No Information
• Device Expiration Date: 04/14/2019
• Device Model Number: QC-2-6-3D
• Device Catalogue Number: QC-2-6-3D
• Device Lot Number: A261070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2020
• Initial Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR