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

Model Number	APB-1.5-2-3D-ES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The axium implant coil was returned within the introducer sheath.The axium implant coil pushwire was found to be bent at ~96.4cm, 104.3cm, and broken at ~135.8cm from proximal end.The axium implant coil assembly was found to be missing and not returned.The axium implant coil tip od (outer diameter) was unable to be measured due to its damaged condition.The id (inner diameter) of the introducer sheath was measured to be 0.0175in which was found to be within specification.Based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ was unable to be confirmed as the axium implant coil was returned without the introducer sheath.The root cause was unable to be determined.The customer reported preparing the axium implant coil as indicated in the ifu prior to use.It is possible insufficient preparation of the axium implant coil, damage during preparation or improper hubbing technique (over tightening of the rhv) could have contributed to the event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the coil did not pass the microcatheter sheath.The devices were prepared as indicated in the ifu.Ancillary device: sl-10 microcatheter.Additional information received reported that the introducer sheath was held vertically when the implant coil was pulled back inside during hydration.

• Brand Name: AXIUM PRIME BARE PL 3D
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 12089416
• Report Number: 2029214-2021-00792
• Device Sequence Number: 3502805
• Product Code: KRD
• UDI-Device Identifier: 00847536031845
• UDI-Public: 00847536031845
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2021

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: 04/14/2023
• Device Model Number: APB-1.5-2-3D-ES
• Device Catalogue Number: APB-1.5-2-3D-ES
• Device Lot Number: B008584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1