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

Model Number	APB-2-6-HX-ES
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	05/21/2019
Type of Reportable Event	Serious Injury
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.No corrective action.Monitoring and trending this type of event.Based on the reported information, there is no evidence suggesting that the device was defective, but rather a procedure related event.However, the exact cause is unknown.Linked mdrs: 2029214-2019-00634 2029214-2019-00635 2029214-2019-00636 2029214-2019-00637 2029214-2019-00638.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that 2 pipeline flex with shield (ped2) were used to re-treat a neck recurrence (2 x 3 x 3mm) of a ruptured and coiled pcoma-aneurysm (initially 8x5x4,5 mm).

• 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: 8744929
• Report Number: 2029214-2019-00636
• Device Sequence Number: 11336917
• Product Code: KRD
• UDI-Device Identifier: 00847536021013
• UDI-Public: 00847536021013
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/07/2019
• Device Model Number: APB-2-6-HX-ES
• Device Lot Number: A239283
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR