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 Paralysis (1997)

Event Date 01/10/2017

Event Type  Injury  

Manufacturer Narrative

This initial mdr is the only report being submitted for mfr report #2954740-2017-00217.Udi: (b)(4).Concomitant medical products: guiding catheter (9fr optimo, tokai medical product), microcatheter (marksman), penumbra 0.074inch, medico's hirata, trevo.(b)(4).The product will not be returned for analysis however a device history record review is currently being conducted and the results are not yet available.Additional information will be submitted within 30 days of receipt.

Event Description

It was reported by a healthcare professional that, as part of the (b)(6) study, a revive se (frs21452299 / s10776) was used on patient number 206-04 during a thrombectomy procedure where hemiplegia was observed post procedure at the upper right lower limb due to hyperfusion phenomenon.On (b)(6) 2017 at 6:30am, acute stage cerebral infarction developed with internal carotid artery system left extracranial internal carotid artery occlusion.The patient was hospitalized at 8:18am.Prior to the procedure, nihss: 19 points, aspects-ct: 8 points, aspects-dwi: 7 points, tici: 0 points.There was almost no tortuousness at the occlusion site and no stenosis to the proximal portion was observed.The vessel diameter and length of the occlusion site were unknown.It was believed that it was a wake up stroke, therefore t-pa was not administered.The puncture time was 9:19am.A guiding catheter (9fr optimo, tokai medical product) was inserted at 9:30am, a microcatheter (marksman) was inserted at 10:15am, and a catheter for thrombus removal (penumbra 0.074inch, medico's hirata) were also used during this procedure.Prior to deployment, mrs: 0.The revive se was deployed three times at the lesion and tici:2a was obtained at 10:20am.Another thrombectomy device (trevo) was deployed once and tici: 2a was obtained at 10:46am.At last, carotid artery stenting (cas) was performed and tici: 2b was obtained at 11:47am and the procedure was completed.The guiding system was removed at 11:54am.Approximately 4 hours after the procedure, hemiplegia was observed at the upper right lower limb due to hyperfusion phenomenon.The patient was sedated, so nihss was not performed.On (b)(6) 2017, it was confirmed that the symptoms of paralysis had resolved.On (b)(6) 2017, aspects-dwi: 6 points.On (b)(6) 2017, nihss: 2 points.On (b)(6) 2017, mrs: 1.In the physician's assessment, the revive se was not the cause of the event; the cerebral hyperfusion phenomenon was considered to be caused by cas.

Manufacturer Narrative

This final mdr is the only report being submitted for mfr report #2954740-2017-00217.The revive se was not returned for investigation.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.Device ineffective and hemiplegia are known potential adverse events associated with use of the revive se device and are listed in the product ifu.All products undergo a 100% inspection prior to being released for sale; there is no evidence of a manufacturing issue related to this complaint.Review of the information suggests that restoration of blood flow in the target lesion area and thrombus conformation may have contributed to the reported events.There is no current safety signal identified related to the reported event(s) based on review of complaint history for the device.No further actions are required at this time.

• 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: 6740532
• MDR Text Key: 80924856
• Report Number: 2954740-2017-00217
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00878528000006
• UDI-Public: (01)00878528000006(17)190430(10)S10776
• 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,Followup
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: FRS21452299
• Device Lot Number: S10776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2017
• Initial Date FDA Received: 07/25/2017
• Supplement Dates Manufacturer Received: 09/15/2017
• Supplement Dates FDA Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 74