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 06/05/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

Jie cao, hang lin, min lin, kaifu ke, yunfeng zhang, yong zhang, weihong zheng, xingyu chen, wei wang, meng zhang, jinggang xuan, and ya peng.Reco flow restoration device versus solitaire fr with the intention for thrombectomy study (redirect): a prospective randomized controlled trial.Journal of neurosurgery (2020).Doi: 10.3171/2020.3.Jns193356.Objective the reco flow restoration (fr) device is a new stent retriever designed for rapid flow restoration in acute ischemic stroke (ais) caused by large vessel occlusion (lvo).Here, the authors compared the efficacy and safety of the reco device with the predicate solitaire fr stent retriever.Methods the reco flow restoration device versus solitaire fr with the intention for thrombectomy study (redirect) was a multicenter, prospective, open randomized controlled trial.Patients with acute lvo at 7 chinese stroke centers participated in the study.The primary efficacy endpoint was defined as a modified thrombolysis in cerebral infarction (mtici) reperfusion grade = 2 within three passes.The primary safety endpoint comprised any serious adverse device effect, symptomatic intracerebral hemorrhage (sich), and any serious adverse event (sae; defined as cerebral palsy or death) within 24 hours after the procedure.The secondary efficacy endpoints consisted of functional independence (modified rankin scale score 0¿2), procedure duration, and 90-day all-cause mortality.Results between january 2014 and august 2016, 67 patients were randomly allocated to the reco group and 69 patients to the solitaire fr group.The primary efficacy endpoint (mtici grade = 2 within three passes) was similar in the two treatment groups (91% vs 87%, respectively, p = 0.5861), and the rate of reperfusion with an mtici grade 2b/3 was 87% versus 75% (p = 0.1272).There were no serious adverse device effects in any patient.The rates of sich (1.5% vs 7.2%, p = 0.1027) and saes (6.0% vs 1.4%, p = 0.2050) within 24 hours after the procedure were similar in the two treatment groups.There was no significant difference in the rate of functional independence (63% vs 46%, p = 0.0609) or 90-day all-cause mortality (13% vs 23%, p = 0.1848) or in procedure duration (85.39 ± 47.01 vs 89.94 ± 53.34 minutes, p = 0.5986) between the two groups.Conclusions the reco stent retriever is effective and safe as a mechanical thrombectomy device for ais due to lvo.- 1 patient in the solitaire group died within 24 hours.- all-cause mortality during 90 days occurred in 16 patients in the solitaire group.

• 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: 11380653
• MDR Text Key: 233691772
• Report Number: 2029214-2021-00207
• 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: 02/25/2021

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
• 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
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 02/25/2021
• 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