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

Catalog Number FRS21452299

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Thromboembolism (2654)

Event Date 10/06/2016

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: guiding catheter (9fr optimo, tokai medical product), micro catheter (marksman, medtronic), trevo pro, prowler select plus, gateway/pta balloon.Getway stryker thrombectomy device, penumbra thrombectomy device.Conclusion: the device was not returned.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 total occlusion and distal embolization of thrombus is a known potential complication associated with the use of the revive se.The root cause of the events could not be conclusively determined; however, procedural/patient factors may have contributed to the event.As per the ifu: ¿contraindications for this device include extreme vessel tortuosity or other conditions preventing the access of the device¿.The ifu also warns that ¿if the revive se device is unable to reach or cross the occlusion, the procedure should be terminated.¿ since there was no evidence to suggest the events were related to a manufacturing issue, no corrective actions will be taken at this time.The revive se is not distributed in the u.S.; however, is similar to the revive pv that is distributed in the u.S.This is an initial/final mdr report.

Event Description

As reported by the revive se pms (b)(4) (patent (b)(4)), the revive se (frs21452299/t10104) partially removed the thrombus (tici 2a), and thrombus migrated distally requiring additional intervention.The patient had presented with acute stage cerebral infarction with vertebral-basilar system midline basilar artery occlusion.Prior to the procedure on (b)(6) 2016, nihss was 8 points.There was mild tortuosity at the occluded site.Vessel diameter proximal to the occlusion was 2.5 mm and distal was 2.1 mm.The thrombus was 10 mm in length, and there was no stenosis proximal to the occlusion.Tpa was not applicable.The revive se was deployed twice at the occluded site with a result of tici 2a.Other thrombectomy devices, including getway/stryker, penumbra 3way, and penumbra/medco¿s hirata were each deployed three times, with a continued result of tici 2a.Finally, the revive se (complaint product) was deployed 3 additional times with a result of tici 2a.During the procedure, thrombus migrated from the distal end of the basilar artery to the left anterior cerebral artery.Since the thrombus was unrecoverable, an enterprise stent was placed from the right posterior cerebral artery to the basilar artery for the purpose of preventing re-occlusion of the basilar artery.Nihss was 6 points immediately after the procedure.On (b)(6) 2016, mrs was 3 points and nihss was 4 points.On (b)(6) 2017, mrs was 1 point.The device was not available for analysis.

• Brand Name: REVIVE - THROMBECTOMY DEVICE
• Type of Device: EMBOLECTOMY CATHETER
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• Manufacturer Contact: karen anigbo ; 821 fox lane; san jose, CA 95131 ; 5088288374
• MDR Report Key: 6503566
• MDR Text Key: 73335520
• Report Number: 2954740-2017-00083
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00878528000006
• UDI-Public: (01)00878528000006(17)190228(10)T10104
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: FRS21452299
• Device Lot Number: T10104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 56