MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SOLITAIRE FR; CATHETER, THROMBUS RETRIEVER

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

Patient Problem Insufficient Information (4580)

Event Date 06/01/2021

Event Type  Death  

Manufacturer Narrative

Baek j-h, jung c, kim bm, heo jh, kim dj, nam hs, kim yd, lim eh, kim j-h, kim jy and kim jh (2021) combination of rescue stenting and antiplatelet infusion improved outcomes for acute intracranial atherosclerosis-related large-vessel occlusion.Front.Neurol.12: 608270.Doi: 10.3389/fneur.2021.608270.This value is the average age of the patients reported in the article as specific patients could not be identified.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Please note that this date is based off of the date of publication of the article [or the date that the article was accepted for publication] as the event dates were not provided in the published literature.If information is provided in the future, a supplemental report will be issued.

Event Description

Baek j-h, jung c, kim bm, heo jh, kim dj, nam hs, kim yd, lim eh, kim j-h, kim jy and kim jh (2021) combination of rescue stenting and antiplatelet infusion improved outcomes for acute intracranial atherosclerosis-related large-vessel occlusion.Front.Neurol.12: 608270.Doi: 10.3389/fneur.2021.608270 medtronic literature review found reported of patient complications in association with solitaire thrombectomy.The purpose of this article was to investigate an optimal endovascular strategy for large-vessel occlusion caused by in situ thrombo-occlusion (icas-lvo).The authors reviewed 184 cases of patients treated for icas-lvo via mechanical thrombectomy or mechanical thrombectomy with an alternate approach.Of the 184 patients, the average age was 68 years, 78 were female and 106 were male.The article does not state any technical issues during use of the solitaire.In addition, a successful recanalization was achieved in 168 patients.The following intra- or post-procedural outcomes were noted: mortality was reported as a clinical outcome for 11 patients who underwent surgery.

• Brand Name: SOLITAIRE FR
• Type of Device: CATHETER, THROMBUS RETRIEVER
• 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: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 12391898
• MDR Text Key: 268931913
• Report Number: 2029214-2021-01091
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K113455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• 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: 08/23/2021
• 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 Outcome(s): Death