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

Catalog Number FRS21452299

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hemorrhage, Cerebral (1889); Vascular System (Circulation), Impaired (2572)

Event Date 01/31/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The lot number could not be provided; therefore, the manufacturing and expiration dates are unknown.Concomitant medical products: guiding catheter (9fr optimo, tokai medical product), microcatheter (marksman, medtronic), penumbra, medico's hirata.T-pa (0.6 mg/kg) was administered.The revive se is not distributed in the united states; however, it is similar to the revive pv that is distributed in the united states.Additional information will be submitted within 30 days of receipt.

Event Description

As reported by the revive se pms japan study ((b)(6)), on 31 jan 2017, the revive se (frs21452299/lot unknown) failed to clear the thrombus and vasospasm occurred, and immediately after the procedure, a small asymptomatic cerebral hemorrhage (ph1) was confirmed at the occluded blood vessel.The patient had initially presented with a cerebral infarction with occlusion in the distal portion of the left middle cerebral artery (m1d).Before the procedure, aspects-ct was 10 points, aspects-dwi was 9 points, nihss was 20 points, tici was 0 points.The proximal portion of the occluded site was mildly tortuous, with the proximal portion 3.0 mm and the distal portion 2.4 mm.The thrombus length was 15 mm.Tpa (0.6 mg/kg) was administered.The revive se was deployed twice at the blocked area with a result of tici 1.There was no difficulty in removing the device from the patient.Occlusion due to vasospasm was observed after the two uses of the revive se, which the investigator felt was related to the revive se.There was no treatment for the vasospasm.Another thrombus ablation device (penumbra) was deployed once, resulting in tici 2b.It was reported that the revive se had been prepped and used as per the instructions for use (ifu).Immediately after the procedure, a small asymptomatic cerebral hemorrhage (ph1) was confirmed at the occluded blood vessel area; however, there was no treatment for the hemorrhage.On (b)(6) 2017, nihss was 6 points.On (b)(6) 2017 aspects-dwi was 7 points.On (b)(6) 2017 nihss was 3 points and mrs was 2 points.On (b)(6) 2017 aspect-ct was 7 points.

Manufacturer Narrative

After three attempts to obtain additional information, including the lot number, no additional information could be obtained from the customer.Conclusion: as reported by the (b)(6) study (patient(b)(6)), on (b)(6) 2017, the revive se (frs21452299/lot unknown) failed to clear the thrombus and vasospasm occurred, and immediately after the procedure, a small asymptomatic cerebral hemorrhage (ph1) was confirmed at the occluded blood vessel.The patient had initially presented with a cerebral infarction with occlusion in the distal portion of the left middle cerebral artery (m1d).Before the procedure, aspects-ct was 10 points, aspects-dwi was 9 points, nihss was 20 points, tici was 0 points.The proximal portion of the occluded site was mildly tortuous, with the proximal portion 3.0mm and the distal portion 2.4mm.The thrombus length was 15mm.Tpa (0.6mg/kg) was administered.The revive se was deployed twice at the blocked area with a result of tici 1.There was no difficulty in removing the device from the patient.Occlusion due to vasospasm was observed after the two uses of the revive se, which the investigator felt was related to the revive se.There was no treatment for the vasospasm.Another thrombus ablation device (penumbra) was deployed once, resulting in tici 2b.It was reported that the revive se had been prepped and used as per the instructions for use (ifu).Immediately after the procedure, a small asymptomatic cerebral hemorrhage (ph1) was confirmed at the occluded blood vessel area; however, there was no treatment for the hemorrhage.On 01 feb 2017, nihss was 6 points.On 02 feb 2017 aspects-dwi was 7 points.On 07 feb 2017 nihss was 3 points and mrs was 2 points.On 09 feb 2017 aspect-ct was 7 points.The device was not returned for analysis.In addition, the lot number of the device could not be obtained from the customer; therefore, a dhr review could not be performed.Continued total occlusion, vasospasm and hemorrhage are known potential complications 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.¿ 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 to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.

Manufacturer Narrative

Additional information was received on 04/03/2017: the lot number of the revive se was t10104.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.(b)(4).There is no change to the baseline conclusion of this complaint.

Manufacturer Narrative

(b)(6).

• 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: 6405658
• MDR Text Key: 70123483
• Report Number: 2954740-2017-00055
• 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,Followup,Followup,Followup,Followup
• Report Date: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• 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: T10104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 75