MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number UNK-NV-AXIUM

Device Problem Migration (4003)

Patient Problems Obstruction/Occlusion (2422); Foreign Body In Patient (2687)

Event Date 05/29/2020

Event Type  Injury  

Event Description

Stanzani, r., yamada, y., kawase, t., devareddy, g., kadam, c., shukurov, f., vaibhav, c., kato, y.(2020).Acute coils migration ca using significant m3 branch occlusion: a case report of rescue surgery with superficial temporal artery-middle cerebral artery bypass.Asian journal of neurosurgery, 15(2), 428.Https://doi.Org/10.4103/ajns.Ajns_349_19.Summary: endovascular coiling has become the mainstay of treatment for both ruptured and unruptured aneurysms in the majority of centers worldwide.Advances in endovascular techniques, including balloons-assisted coiling procedure, have been applied in intracranial aneurysms.Coil migration is a potential rare complication of this kind of procedure and may have catastrophic consequences if not adequately managed.We present here a rare complication of acute coil migration after balloon-assisted coil embolization.Identified events: 1.A (b)(6) year-old female underwent a balloon-assisted coil treatment.After the procedure, the aneurysm seemed to be completely embolized but, after balloon deflation, the coils migrated and caused a significant occlusion of m3 branch with severe reduction of flow.After early patient clinical deterioration (glasgow coma scale score 14) without other neurological deficit, it was considered that the migrated coils were too deep and the occluded vessel was too small to perform endovascular/surgical removal of the coils, thus it was decided to perform bypass to restore cerebral perfusion distal to the occlusion.The patient was discharged after 10 days, without neurological deficit.See attached literature article.

Manufacturer Narrative

Stanzani, r., yamada, y., kawase, t., devareddy, g., kadam, c., shukurov, f., vaibhav, c., kato, y.(2020).Acute coils migration ca using significant m3 branch occlusion: a case report of rescue surgery with superficial temporal artery-middle cerebral artery bypass.Asian journal of neurosurgery, 15(2), 428.Https://doi.Org/10.4103/ajns.Ajns_349_19.Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AXIUM
• Type of Device: DEVICE, NEUROVASCULAR 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: 13490399
• MDR Text Key: 288798446
• Report Number: 2029214-2022-00190
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK-NV-AXIUM
• Device Catalogue Number: UNK-NV-AXIUM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2022
• 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 Outcome(s): Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female