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

Model Number APB-5-20-HX-SS

Device Problems Stretched (1601); Unintended Movement (3026)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/24/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding an axium coil that stretched with a segment extending into the parent vessel.The patient was undergoing a coil embolization procedure to treat an unruptured saccular posterior communicating artery aneurysm.The aneurysm max diameter was 5mm and the neck diameter was 2mm.Bloor flow and vessel tortuosity were normal.It was reported that the axium coil (model: apb-5-20-hx-ss, lot: b165311) was the third to be implanted during the procedure.After entering the aneurysm, part of the axium coil stretched with a segment extending into the parent vessel and could not be withdrawn.The procedure was halted.The pusher was withdrawn after cutting the wire in vitro.A rebar catheter was used to deploy a solitaire ab (sab) stent to hold the coil in place.Two additional coils were subsequently placed successfully.There were no patient symptoms or other complications associate with this event.

Manufacturer Narrative

Product analysis: ¿ as found condition: the axium prime coil was returned for analysis within a shipping box; within a plastic bio-pouch, within an opened axium prime inner pouch (b165311), and within a dispenser coil.¿ visual inspection/damage location details: the axium prime pusher actuator interface (ai) and hypotube break indicator (hbi) were found intact.No bends or kinks were found with the pusher.The release wire coin was found against the lumen stop.The implant coil was found not attached to the pusher.The implant coil was found to have broken off from the pusher from the coil shell weld.In addition, the implant coil polypropylene filament broke off from the detach element.The implant coil was not returned as it remains within the patient.¿ testing/analysis: none ¿ conclusion: based on the device analysis and reported information, the customer¿s ¿coil stretch¿ report was confirmed.It is likely that the implant coil became stretched subsequently breaking off from the pusher during removal.However, the cause for the reported event could not be determined.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AXIUM PRIME BRPL HLX
• Type of Device: 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: 12372595
• MDR Text Key: 268303906
• Report Number: 2029214-2021-01071
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00847536032354
• UDI-Public: 00847536032354
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K081465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2024
• Device Model Number: APB-5-20-HX-SS
• Device Catalogue Number: APB-5-20-HX-SS
• Device Lot Number: B165311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: 10/31/2021
• Supplement Dates FDA Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Female