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

Model Number UNK-NV-SFR

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

Patient Problem Insufficient Information (4580)

Event Date 01/01/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

Yuan pu.Comparison of different types of endovascular mechanical embolectomy in acute ischemic stroke.Rev assoc med bras 2019; 65( 3):342-347.Doi:10.1590/1806-9282.65.3.342 summary background: to compare the treatment efficacy of different types of endovascular mechanical embolectomy in acute ischemic stroke (ais).Material and methods: a total of 89 patients with ais were selected in our hospital from january 2014 to january 2016 and divided into tpa group (n=27), tpa+trevo group (n=30) and tpa+solitaire fr group (n=32) for different treatments.Treatment effectiveness was evaluated using nihss and mrs system.The nihss score, vascular recanalization rate and postoperative complications were compared among groups.Results: the nihss score of the tpa group was significantly lower than that of other two groups at 1 d after the operation (p < 0.05), but it was significantly higher than that of other two groups at 3 d and 3 w after the operation (p < 0.05).After the treatment, no significant difference in nihss score was found between the tpa+trevo and tpa solitaire fr groups.The revascularization rate was significantly higher, but the mortality rate in 90 d was significantly lower in the tpa+trevo and tpa+solitaire fr groups than that in the tpa group (p < 0.05), and no significant difference was found between the tpa+trevo and tpa+solitaire fr groups.The incidence rate of symptomatic intracranial hemorrhage was significantly lower in the tpa+solitaire fr group than that in tpa+trevo group (p< 0.05) or tpa group (p < 0.01).Significantly more patients with mrs no hi gher than 2 points were found in the tpa+trevo and tpa+solitaire fr groups than those in tpa group (p< 0.05), and no significant difference was found between the tpa+trevo and tpa+solitaire fr groups.Conclusion: tpa+solitaire fr is a type of thrombectomy that is superior to tpa and tpa+trevo in the treatment of patients with ais.- mortality at 90 days occurred with 4 patients.

• 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: 11385810
• MDR Text Key: 233775166
• Report Number: 2029214-2021-00211
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-SFR
• Device Catalogue Number: UNK-NV-SFR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2021
• 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