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	Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The coil was reported to have been implanted in the patient.Since the device was not returned, we are unable to perform further root cause analysis and the exact cause of the reported event is unknown.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 that during the coiling procedure, the first coil¿s pushwire was alleged to have broken.When the second coil was advanced through the headwayduo (competitor device) catheter resistance was felt and the first implanted coil was moved.The first and the second coil were alleged to have entangled."according to ifu, the reported product was prepared, and the coil was inserted through the microcatheter.After the coil was successfully completed, it was detached, and the delivery system was retrieved.Although the detachment seemed to have been performed without a problem with aligning the second marker, a strong resistance was encountered when the second coil was inserted after the delivery system was retrieved, and the first coil started to move when inserted without any action.The first coil (broken product) and the second coil were tangled and moved, and after the second coil was retrieved once, the microcatheter was retrieved together, the delivery shaft of the first coil remained and it was found that it was stretched." the stretched delivery system was difficult to retrieved, so it remained in the body, the microcatheter was re-approached and the second coil was inserted.After that, it was completed without problems.As a result, the tip of the delivery shaft, about 3 mm, remained in the body along with the first coil implantation.No patient injury occurred.The vessel anatomy was severe in tortuosity.The blood flow was normal.The devices were prepared and used per the instructions for use (ifu).The catheter was flushed per the ifu.The second coil was apb-1.5-4-3d-es, lot # a884302.The treating location was 2 mm in diameters.Characteristic was slightly vertical.By the end of procedure, the coils were placed back into the intended location.New coils were also implanted into the aneurysm.Post the procedure the patient was asymptomatic and did not sustain an adverse event.

• 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: 10018128
• Report Number: 2029214-2020-00425
• Device Sequence Number: 2168016
• Product Code: KRD
• UDI-Device Identifier: 00847536021167
• UDI-Public: 00847536021167
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/01/2020

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: Health Professional
• Device Expiration Date: 08/16/2022
• Device Model Number: APB-1.5-4-3D-ES
• Device Lot Number: A884302
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 05/01/2020
• 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: Other