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 No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2016

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: guiding catheter (9fr cello, fuji systems), microcatheter (marksman, medtronic).Udi: (b)(4).Conclusion: 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.The ifu warns that ¿if the revive se device is unable to reach or cross the occlusion, the procedure should be terminated.¿ i is unknown if additional attempted use of the revive se would have been successful in removing clot since it appears the vessel puncture unrelated to the revive se may have interrupted treatment.Since there was no evidence to suggest the inability to remove clot was 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, 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 (patient (b)(6)), the revive se (frs21452299/t10111) was unable to remove the thrombus, and the patient experienced subarachnoid hemorrhage due to vessel puncture by the non-codman microcatheter.The patient had presented with acute stage cerebral infarction with distal portion of the middle cerebral artery occlusion.Before the procedure, aspects-dwi was 7points and nihss was 24 points.There was almost no vessel tortuosity at the occluded site.The vascular diameter and length was unknown.T-pa (0.6mg/kg) was administered, but the vessel was not re-canalized, so the revive se was used for the procedure.A guiding catheter (9fr cello, fuji systems and a microcatheter (marksman, medtronic were also used for the procedure.The revive se was deployed once at the lesion, and tici 0 was obtained.The revive se was used as per the instructions for use (ifu).When the microcatheter was handled for the 2nd deployment, before inserting the revive se, the vessel was punctured by mistake at the occluded area.The patient experienced asymptomatic subarachnoid hemorrhage and the guiding system was removed.Information regarding subsequent treatment could not be obtained.Nihss was not performed immediately after the procedure.At some point after the procedure, mrs was 5points, nihss was 19points, and aspects-c was 0 points.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: 6503076
• MDR Text Key: 73349609
• Report Number: 2954740-2017-00081
• Device Sequence Number: 1
• Product Code: DXE
• 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: 03/30/2017

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: T10111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 94 YR