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

Model Number	APB-2-6-HX-ES
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the axium prime coil was stuck in the center of the microcatheter.While pulling it back, it broke into 2 pieces consecutively. the event was said to be not associated with the patient. the devices were prepared according to the instructions for use (ifu).Ancillary devices include an sl-10 microcatheter.Additional information received reported that the coil come out of the introducer sheath smoothly.The coil pieces were able to be removed with the catheter.
Additional Manufacturer Narrative
This event was previously reported in manufacturer's report # 2029214-2022-00785.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Additional Manufacturer Narrative
H3.Product analysis: equipment used: video inspection system (m-78210), ruler 200cm (m-83361), camera (panasonic lumix dmc-zs5) as found condition: the axium prime coil and sl-10 catheter were returned for evaluation within the outer carton; inside of a biohazard bag and a shipping box.The sl-10 catheter appeared to be compatible for use with the coil as it has a labeled inner diameter (id) of 0.0165¿.Visual inspection/damage location details: the implant coil appeared to be damaged and stretched within sheath.After removal from the introducer sheath, the implant coil was found to be damaged and stretched with the polypropylene filament intact.No separation was observed on the returned coil.The pushwire was found to be bent at 6.5cm from the proximal end.The sl-10 catheter body appeared to be kinked at 13.0cm, 43.5cm and 100.5cm from the hub.No flash or voids molded were observed in the hub.Testing/analysis: the catheter was flushed with water and water exited out from the distal tip.The returned coil and catheter could not be used for resistance testing due to the damaged conditions.Conclusion: based on the analysis findings, the axium prime coil was confirmed to have ¿coil resistance/ stuck in catheter¿ issue as the returned coil were damaged and stretched.In addition, the sl-10 catheter was found damaged at several locations.It is likely that these damages occurred when the customer attempted to advance the coil through the catheter against the reported resistance.However, the cause for resistance could not be determined.Possible causes of resistance include the use of damaged catheter, patient tortuous anatomy and lack of continuous flush with heparinized saline during delivery.The customer complaint of "coil separation" was not confirmed as the returned coil was found intact, but damaged and stretched.There was no non-conformance to specifications identified that led to the reported issues.H6.Coding updated based on analysis results.Associated with rr#: 2029214-2022-00785.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: AXIUM PRIME BRPL HLX
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 14914825
• Report Number: 2029214-2022-01099
• Device Sequence Number: 12305938
• Product Code: KRD
• UDI-Device Identifier: 00847536021013
• UDI-Public: 00847536021013
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2022

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: 11/03/2024
• Device Model Number: APB-2-6-HX-ES
• Device Catalogue Number: APB-2-6-HX-ES
• Device Lot Number: 223240015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 07/05/2022
• Supplement Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown