MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 GOOSENECK SNARE; CATHETER, PERCUTANEOUS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Thromboembolism (2654)

Event Date 10/29/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The gooseneck micro snare was used on 5 of the 18 patient population in the study.Case 1 had a retrieval complication of thromboembolism and neurological effect with an outcome of severe disability.Case 2 had a retrieval complication of thromboembolism with an outcome of death.Case 7 had no retrieval complication but had an outcome of death.Case 11 had a hemorrhagic retrieval complication and neurological effect with an outcome of severe disability.Case 14 had no retrieval complication but had an outcome of minor neurological effect with good recovery.It was reported in the literature article, coil migration during or after endovascular coiling of cerebral aneurysms, that a retrospective analysis of the clinical and radiological data of patients who underwent cerebral aneurysm coiling complicated by coil migration at five neuroendovascular centres in the united states, canada, and france between 2008 and 2018.This retrospective study involved 18 patients that met the study criteria.Patients managed conservatively (5/18, 28%) did well.Thromboembolic and/or hemorrhagic complications were noted in 6/10 migration patients treated by endovascular modalities and in all migration patients who underwent surgical treatment (4/4).Three deaths occurred (3/18, 17%) related to high hunt and hess grade subarachnoid hemorrhage.It was concluded that coil migration is an uncommon but important complication of cerebral aneurysm coiling.Small aneurysms, aspect ratio 1.6, and small coils are significant risk factors.Endovascular treatment, such as using a stent retriever, can be considered for procedural, proximal migration, and/or in cases of vessel occlusion.Delayed or distal migration should be managed conservatively.

• Brand Name: GOOSENECK SNARE
• Type of Device: CATHETER, PERCUTANEOUS
• 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: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 10141953
• MDR Text Key: 195602511
• Report Number: 2029214-2020-00540
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2020
• 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): Other
• Patient Age: 56 YR