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 Intracranial Hemorrhage (1891)

Event Date 03/20/2016

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Conclusion: the device was not returned 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 total occlusion is a known potential complication associated with the use of the revive se.The root cause of the event 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.¿ hemorrhage and stroke are known potential complications associated with the revive se.The root cause of the event could not be determined; however, patient and pharmacologic factors may have contributed to the event.The patient had presented with neurological symptoms and received thrombolytic treatment during the procedure which could increase the likelihood of developing hemorrhagic transformation.Since there was no evidence of a manufacturing issue related to the event, no corrective actions will be taken at this time.The revive se is not distributed in the u.S.; however, it is similar to the revive pv that is distributed in the u.S.This is an initial/final mdr report.

Event Description

As reported via the (b)(6) study, (case (b)(6)), the revive se (frs21452299/t10088) was unable to remove thrombus, and the patient experienced asymptomatic intracranial hemorrhage approximately 20 hours post-procedure.The patient had presented with acute stage cerebral infarction with internal carotid artery, right middle cerebral artery (m1) occlusion.Prior to the procedure, aspects-dwi was 6 points, nihss was 21 points and tici was 0 points.There was mild vessel tortuosity at the occluded site and there was no stenosis at the proximal portion of the occlusion.On (b)(6) 2016, t-pa (0.6mg/kg) was administered, but there was no recanalization.The revive se was deployed twice at the occluded site, but tici remained 0.The revive se had been prepped and used as per the instructions for use (ifu).A solitaire was deployed once, and tici 3 was obtained.Immediately after the procedure, nihss was 23 points.On (b)(6) 2016, the patient recovered with mrs of 5 points.On (b)(6) 2016, mrs was 4 points.

• 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: 6519236
• MDR Text Key: 73619462
• Report Number: 2954740-2017-00088
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00878528000006
• UDI-Public: (01)00878528000006(17)180930(10)T10088
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: FRS21452299
• Device Lot Number: T10088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 55