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

Model Number	APB-1.5-4-3D-ES
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The axium prime pusher was returned without the instant detacher, microcatheter, or the accessories devices.The axium prime pusher was decontaminated.The actuator interface was found kinked and completely detached from the coupler tube with the release wire attached to the actuator interface.This is indicative that a possible mechanical detachment attempt was performed using an instant detacher.No other damages were found with the pushwire.The implant coil was already detached from the pushwire and not returned for analysis.The introducer sheath was found correctly assembled on the pushwire with the wavelock at the proximal end.No damages were found with the introducer sheath.No other anomalies were observed.Based on the analysis performed, the report of ¿coil stretch¿ could not be confirmed as the axium prime implant coil was not returned for analysis.There is evidence that a mechanical detachment attempt using an instant detacher was performed as the actuator interface was detached from the coupler tube and the release wire was pulled completely out of the pushwire.Since the instant detacher and microcatheter were not returned, any contribution of the instant detacher and microcatheter to the ¿coil stretch¿ could not be determined.Per the axium prime detachable coil and i.D.(instant detacher) instructions for use (ifu): warning: "if the coil does not move with a one-to-one motion, or repositioning is difficult, the coil has been stretched and could possibly break.Gently remove and discard both the catheter and coil." if information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that this coil stretched while filling an aneurysm.The physician removed the coil from the catheter.The patient underwent embolization treatment for a small unruptured saccular anterior communicating artery aneurysm.Measuring 5.5mmx2.5mm there were not any patient symptoms or complications associated with this event.No images available for review.The patient¿s blood flow was normal.The vessel was moderately tortuous.Reported device and any accessory devices were prepared as indicated in the ifu.No patient injury was reported.There was not any friction or difficulty during testing or delivery.Yes, the continuous flush administered during the procedure.The physician did not reposition the coil during the procedure.6f envoy da, excelsior-10 45 and 90, synchro wire.

• Brand Name: AXIUM PRIME BARE PL 3D
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8866421
• Report Number: 2029214-2019-00818
• Device Sequence Number: 2514214
• Product Code: KRD
• UDI-Device Identifier: 00847536021167
• UDI-Public: 00847536021167
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K151447
• 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): 08/06/2019

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: 08/19/2021
• Device Model Number: APB-1.5-4-3D-ES
• Device Lot Number: A695364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2019
• Initial Report FDA Received Date: 08/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1