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

Model Number	APB-2-8-HX-ES
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the coil became stretched while pulling it out of the aneurysm.As the event indicated a possible failure of a device, labeling, or packaging to meet any of its specifications, an investigation was required.Additional information was required to investigate the event and/or determine the cause of the event.The health care professional was contacted for additional information to help with the investigation.The axium prime coil was returned for analysis with the non-medtronic micro catheter (stryker excelsior sl-10) used in the event.Analysis found that based on the device analysis and reported information, the customer¿s report of ¿coil stretch¿ was confirmed.The implant coil was found stretched damaged and broken.No damages or irregularities were found with the axium prime pusher.The coin was still against the lumen stop.The shield coil was found intact and the detach element was still attached to the pusher.The implant coil was found broken from the detach element with the polypropylene filament also broken and returned separately.The axium prime implant coil was found to be stretched and damaged.No damages or irregularities were found with the sl-10 hub.The sl-10 micro catheter body was found kinked near the distal end.The micro catheter tip and marker band were found slightly crushed.The distal tip could not be measured due to the damages.A mandrel was inserted through the catheter hub and became stuck at the proximal kinked location.All other subassemblies appeared to be normal and no other anomalies were observed.There was no indication that the event was related to a possible manufacturing issue, so a device history record review was not performed.Possible causes for coil stretch/damage/break are lack of hydration before procedure, user does not maintain continuous flush, tortuous anatomy, coil not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation, incompatible catheter or advancing/retracting the device against resistance.It is likely the damages found on the micro catheter contributed towards resistance and the coil stretch/damage/break.The investigation determined that this was a known event.Common sequences of events and contributing factors that can lead to this known event are documented in the risk management file.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the coil became stretched while pulling it out of the aneurysm.Continuous flush was administered during the procedure.The physician repositioned the coil 2-3 times during the procedure.The device was removed and replaced to complete the procedure.The patient was undergoing surgery to treat an unruptured, saccular aneurysm located at the posterior communicating artery with a max diameter of 6.2 mm and a neck diameter of 3.6 mm.It was noted the vessel tortuosity was moderate.There were no patient symptoms associated with the event.The devices were prepared as indicated in the ifu.There was no harm or injury to the patient.Additional information received reporting that the catheter passed through the introducer sheath smoothly.There was no resistance felt in the catheter during delivery or retrieval of the coil.The rep stated the device was returned but tracking information was unknown.No additional information received.

• 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: 10287568
• Report Number: 2029214-2020-00699
• Device Sequence Number: 19726545
• Product Code: KRD
• UDI-Device Identifier: 00847536021020
• UDI-Public: 00847536021020
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/16/2020

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 Model Number: APB-2-8-HX-ES
• Device Lot Number: A985272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 07/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 50