MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL REVIVE - THROMBECTOMY DEVICE; MICRUS THROMBECTOMY

Catalog Number FRS21452299

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2015

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2015: ct scan aspect score for anterior circulation: 8 pre-procedure modified rankin score: 0, pre-procedure nihss score: 22 pre-procedure tici score: 0 post revive se tici score: 1 end of procedure tici score: 2b.(b)(4).Complaint conclusion: the device was not available for analysis.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Continued occlusion is a known procedural complication associated with thrombectomy devices.Based on the information provided, and no product return for analysis, it is not possible to definitively determine the root cause of the partial thrombectomy.Since the thrombus was finally removed with a larger stent, thrombus characteristics may have contributed to the event.There was no evidence provided to suggest the event was related to a manufacturing issue; therefore, no corrective actions will be taken at this time.Revive se is not marketed in the united states, but is similar to revive pv that is marketed in the united states.This is an initial/final mdr report.

Event Description

As reported via the re-act study, partial thrombectomy was achieved during use of the revive se (catalog/lot unk).At the time of the index procedure, after two passes to clear the clot with the revive se (frs214522-99/ t10066) resulting in partial thrombectomy, the basket was reconstrained in the microcatheter and removed.Thrombectomy was completed with use of a trevo 6mm and a solitaire 4mm.Tici score post revive se was 1, and tici score at end of the procedure was 2b.The following day, imaging revealed non-symptomatic intracranial hemorrhage near the treatment vessel, and the nihss score was 21.According to the investigator, the hemorrhage was not related to the revive, but was related to punctiform bleeding due to large ischemic core.Prior to the procedure, the patient had presented with symptoms consistent with ischemic stroke, and a 15mm left middle cerebral artery (m1) thrombus.Pre-procedure modified rankin score was 0, nihss score was 22, tici score was 1, and ct scan aspect score for anterior circulation 8.The diameter of the artery distal to the thrombus was 1.2mm, and diameter of the artery proximal to the thrombus was 2mm.The patient was initially treated with iv lytic (rt-pa 63mg/kg) and syringe aspiration.There had been no difficulty in getting the revive se through the clot, and the device was used and performed as per the instructions for use.The event did not result in a clinically significant delay in the procedure, since the device was quickly exchanged for a larger stent.According to the investigator, the revive se partial thrombectomy was possibly related to the revive se, but not serious.The patient was discharged to a re-education center due to right hemiplegia approximately 2 weeks after the procedure.

• Brand Name: REVIVE - THROMBECTOMY DEVICE
• Type of Device: MICRUS THROMBECTOMY
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• Manufacturer Contact: kimberly soter ; 821 fox lane; san jose, CA 95131 ; 5088288310
• MDR Report Key: 5402184
• MDR Text Key: 37785231
• Report Number: 2954740-2016-00029
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: FRS21452299
• Device Lot Number: T10066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 63