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

Model Number	APB-2.5-4-HX-ES
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that this coil would not detach with an instant detacher or using manual detachment method (breaking hypotube method; an alternative method presented in the instruction for use).The patient underwent embolization treatment a small unruptured saccular left posterior communicating artery aneurysm, measuring 5mmx24mm.The vessel was normal tortuous.It was reported that the physician attempted to detach the coil two times with first instant detacher and two times with second instant detacher but did not detach.The physician attempted to detach the coil using manual method five times but still coil did not detach.There was no patient symptoms or complications associated with this event.No images available for review.The patient¿s blood flow was normal.No patient injury was reported.Reported device and any accessory devices were prepared as indicated in the ifu.

• Brand Name: AXIUM PRIME BRPL HLX
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9163390
• Report Number: 2029214-2019-00994
• Device Sequence Number: 19371040
• Product Code: KRD
• UDI-Device Identifier: 00847536021044
• UDI-Public: 00847536021044
• 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: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/07/2019

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: 04/19/2022
• Device Model Number: APB-2.5-4-HX-ES
• Device Lot Number: A818482
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 10/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR