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

Model Number	APB-1.5-2-HX-ES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis #(b)(4):equipment used: vis (m-77148), 203cm ruler (m-83360) the axium prime coil (model: apb-1.5-2-hx-es; lot: a769317) was returned for analysis within a shipping box; within a sealed plastic bio-pouch; and within a dispenser coil.The microcatheter used in the event was not returned.The microcatheter has a labeled id (inner diameter) of 0.0165, as per an online source.Per the axium prime coil ifu (instructions for use): axium prime detachable coils should be delivered through a microcatheter with a minimum inside diameter of 0.0165, 0.017, with two marker bands, therefore, the microcatheter was found to be compatible for use with the axium prime coil.The axium prime implant coil was found to be detached from pushwire, and not returned.Therefore, any contributing factors could not be assessed.The axium prime pushwire was decontaminated as per manufacturer protocol.The axium prime pushwire was returned within the introducer sheath.The introducer sheath was found correctly assembled on the pushwire with the wavelock at the proximal end.The axium prime pushwire appeared to be broken at positive load indicator, and retained by release wire.In addition, the axium prime pushwire was found to be bent at ~8.6cm from proximal end.No damages or irregularities were found with the introducer sheath.The axium prime pushwire was able to be pushed out from the introducer sheath.Due to its damaged condition, the axium prime coil could not be used for resistance testing with an in-house cat heter.No other anomalies were observed.There was no indication that the event was related to a potential manufacturing issue.Based on the device analysis and reported information, the customers report of coil resistance/stuck in catheter hub could not be confirmed and the cause could not be determined.Possible causes for coil resistance at catheter hub are, but not limited to, failure to hydrate the coil prior to use, failure to utilize continuous flush, failure to use a compatible microcatheter for delivery, and use of an improper hubbing technique (over tightening of the rhv/sheath firmly seated into hub).Improper hubbing technique could not be ruled out as a potential root cause for the event.The customer reported preparing the axium prime coil prior to use (which includes implant coil hydration) and the microcatheter was found to be compatible for use with the axium prime coil.It was reported that the introducer sheath was not held vertically when the implant coils were pulled back inside during hydration.The patients vessel tortuosity was moderate.Information regarding if a continuous flush was used was not reported.Therefore, any contributing factors could not be assessed.It is likely that the damage to the implant coil and the pushwire occurred during the attempt to push the coil through the micro catheter against the reported resistance.However, the cause of resistance could not be determined.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that two axium coils would not go into the catheter hub.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the piarachnoid an with a max diameter of 6mm and a 4mm neck diameter.It was noted the patient's vessel tortuosity was moderate.It was reported that two axium coils would not go into the catheter hub.A replacement product was used to complete the procedure.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms, or further complications were reported as a result of this event.Additional information was received reporting that the introducer sheath was not held vertically when the implant coils were pulled back inside during hydration.The coils came out of the introducer sheaths smoothly.No damage was observed to the coils.

• 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: 10991569
• Report Number: 2029214-2020-01283
• Device Sequence Number: 14322094
• Product Code: KRD
• UDI-Device Identifier: 00847536020948
• UDI-Public: 00847536020948
• 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): 12/11/2020

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: 01/17/2022
• Device Model Number: APB-1.5-2-HX-ES
• Device Catalogue Number: APB-1.5-2-HX-ES
• Device Lot Number: A769317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 12/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1