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U.S. Department of Health and Human Services

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

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MEDOS INTERNATIONAL SARL REVIVE - THROMBECTOMY DEVICE; EMBOLECTOMY CATHETER Back to Search Results
Catalog Number FRS21452299
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Intracranial Hemorrhage (1891)
Event Date 03/12/2017
Event Type  Injury  
Manufacturer Narrative
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 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.Hemorrhage and stroke are also 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.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, 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 revive se pms (b)(6) ((b)(6)), who presented with cardiogenic cerebral infarction, expired due to intracranial hemorrhage at the occluded blood vessel site within 24 hours of thrombectomy with a revive se ((b)(4)) which only partially removed the clot.The patient had presented with internal carotid artery/right middle cerebral artery (m1) occlusion.Before the procedure on (b)(6) 2017, aspects-ct was 8 points, aspectsd-dwi was 8 points, nihss was 11 points.There was moderate vessel tortuosity at the occlusion site.The vascular diameter at the proximal occlusion site was 2.5mm.Length of thrombus was unknown.It was reported that t-pa was not applicable.The revive se was deployed once at the lesion, with a result of tici 2a.Also, another device was deployed once with tici of 3.The symptomatic intracranial hemorrhage was confirmed at the occluded blood vessel region seven hours after the procedure.Cerebral edema, disturbance of consciousness and respiratory failure was observed as symptoms caused by the symptomatic intracranial bleeding within 24 hours.The symptoms worsened and the patient expired on (b)(6) 2017.
 
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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 Key6503640
MDR Text Key73222774
Report Number2954740-2017-00084
Device Sequence Number1
Product Code DXE
UDI-Device Identifier00878528000006
UDI-Public(01)00878528000006(17)190228(10)T10110
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation Health Professional
Type of Report Initial
Report Date 03/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2019
Device Catalogue NumberFRS21452299
Device Lot NumberT10110
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/17/2016
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age86 YR
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