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 09/01/2013

Event Type  Death  

Manufacturer Narrative

P.F.Xing, p.F.Yang, z.F.Li, l.Zhang, h.J.Shen, y.X.Zhang, y.W.Zhang and j.M.Liu american journal of neuroradiology march 2020, 41 (3) 469-476; doi.Org/10.3174/ajnr.A6414.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 beginning of the range provided in the article: september 2013 to november 2018.If information is provided in the future, a supplemental report will be issued.

Event Description

P.F.Xing, p.F.Yang, z.F.Li, l.Zhang, h.J.Shen, y.X.Zhang, y.W.Zhang and j.M.Liu american journal of neuroradiology march 2020, 41 (3) 469-476; doi.Org/10.3174/ajnr.A6414 medtronic literature review found reported of patient complications in association with solitaire thrombectomy.The purpose of this article was evaluate the comparative safety and efficacy of preferred aspiration thrombectomy and stent retriever thrombectomy for revascularization in patients with isolated terminal internal carotid artery (ica) occlusion.The authors reviewed 109 cases of patients treated for terminal ica occlusion using either aspiration thrombectomy (40 patients) or stent retriever thrombectomy (69 patients).Of the 109 patients, the average age was 69 years, 60 were female and 49 were male.The article does not state any technical issues during use of the solitaire (solitaire fr 6x30 and 4x20), rebar, or navien devices.The following intra- or post-procedural outcomes were noted: 18 patients died under an "all cause" mortality category at 90 days.

• 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: 12197308
• MDR Text Key: 262476043
• Report Number: 2029214-2021-00885
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/12/2021
• Initial Date FDA Received: 07/20/2021
• 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
• Patient Age: 69 YR