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

Catalog Number FRS21452299

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Death (1802); Hemorrhage, Cerebral (1889); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

This is one of one initial/final report being submitted for this complaint.Exact time and date of the hemorrhage is unknown.(b)(4).Concomitant medical products: synchro soft 14in guide wire; trevo xp provue retriever ; intermediate catheter (type/lot unknown).The revive se will not be returned, therefore the root cause of the relationship to the patient injury cannot be determined; however the investigator stated that the hemorrhage was unrelated to the revive se.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.Therefore, no corrective actions will be taken at this time.

Event Description

As reported via the (b)(6) study, thrombectomy was performed using revive se (frs21452299/t10082) on (b)(6) 2016.Prior to the procedure, the patient had presented with symptoms consistent with ischemic stroke and a right middle cerebral artery (m1) thrombus.Pre-procedure modified rankin score was 0, nihss score was 17 and tici score was 0.During the procedure, there was no difficulty getting the revive past the clot and after three passes to clear the clot with the revive se, basket was pulled up to the intermediate catheter (type/lot unknown) and both the catheter and revive were removed together through the primary guide.Synchro soft guide wire and trevo xp provue retriever were also used for the thrombectomy.The revive se device was used as per instructions for use.There were no technical complications or adverse events during the procedure and there was no surgical delay.Tici score at the end of the procedure was 2a.At the 24-hour follow-up the nihss score was 20 and the imaging confirmed non-symptomatic intracerebral hemorrhage.The hemorrhage was not in vessel that was treated with revive se.On (b)(6) 2016 the mrs score was 5 and nihss score was 33.The adverse event was reported to be serious with coma glasgow scale of 3.There were no treatments provided for the hemorrhage.The patient died on (b)(6) 2016.According to the investigator the hemorrhage was unrelated to revive se and possible related to the patientunderlying disease.There were no device malfunctions reported.

Manufacturer Narrative

This is follow-up mdr report submitted for this complaint.Initial mdr report 2954740-2016-00103 was submitted on 09may2016, however after further information was received, the event does not meet criteria for medwatch reporting.Product device is unrelated to the event.Therefore, please note that no further information will be forthcoming for this report.(b)(4).

• 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: karen anigbo ; 821 fox lane; san jose, CA 95131 ; 5088288374
• MDR Report Key: 5640858
• MDR Text Key: 44734954
• Report Number: 2954740-2016-00103
• Device Sequence Number: 1
• Product Code: NRY
• 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,Followup
• Report Date: 04/18/2016

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: FRS21452299
• Device Lot Number: T10082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2016
• Initial Date FDA Received: 05/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 0
• Patient Outcome(s): Death; Hospitalization