MAUDE Adverse Event Report: REFER TO SECTION H10 REVIVE SE 4.5MM OUS; EMBOLECTOMY CATHETER

Catalog Number FRS21452299

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Revive se is not distributed in the u.S.; however, it is similar to the revive pv that is distributed in the u.S.Patient race and ethnicity were not reported.(b)(4).Concomitant med products due to character limitation: 9f cello guiding catheter, marksman microcatheter, penumbra thrombectomy device.Initial reporter - the customer provided.(b)(4).Complaint conclusion: as reported via the revive se pms (b)(6) study ((b)(6)), during a thrombectomy of an occlusion in the middle cerebral artery (distal m1 segment) of the internal carotid artery, a 4.5 mm revive se thrombectomy device (frs21452299/t10084) was deployed four times at the target lesion but the thrombus could not be removed.Thrombolysis in cerebral infarction (tici) score of 2a was obtained.A competitor device was deployed once at the site of the occlusion and tici score of 2b was achieved.Prior to the index procedure, the patient¿s alberta stroke program early ct score (aspects) was 10, aspects-dwi score was 5, nihss score was 15, and tici score was 0.The patient initially presented with an acute stage cerebral infarction on (b)(6) 2016.The site of the occlusion was heavily tortuous.There was reportedly no stenosis proximal to the occlusion.Tissue plasminogen (tpa) was administered without success.A 9f cello guiding catheter, marksman (medtronic) microcatheter, and penumbra thrombectomy device were also used in the case.No further information was provided.The device was not returned for investigation.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.Continued total occlusion is a known potential complication associated with the use of the revive se.The event narrative indicates that the site of the occlusion was heavily tortuous.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 root cause of the event could not be conclusively determined; however, patient and procedural factors may have contributed to the event.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

As reported via the revive se pms (b)(6) study ((b)(6)), during a thrombectomy of an occlusion in the middle cerebral artery (distal m1 segment) of the internal carotid artery, a 4.5 mm revive se thrombectomy device (frs21452299/t10084) was deployed four times at the target lesion but the thrombus could not be removed.Thrombolysis in cerebral infarction (tici) score of 2a was obtained.A competitor device was deployed once at the site of the occlusion and tici score of 2b was achieved.Prior to the index procedure, the patient¿s alberta stroke program early ct score (aspects) was 10, aspects-dwi score was 5, nihss score was 15, and tici score was 0.The patient initially presented with an acute stage cerebral infarction on (b)(6) 2016.The site of the occlusion was heavily tortuous.There was reportedly no stenosis proximal to the occlusion.Tissue plasminogen (tpa) was administered without success.A 9f cello guiding catheter, marksman (medtronic) microcatheter, and penumbra thrombectomy device were also used in the case.The product will not be returned for analysis.No further information was provided.

Manufacturer Narrative

Product complaint # (b)(4).Section b5:.Additional information received indicated that no intraprocedural adverse events/product malfunctions occurred.There was no evidence of vessel damage/rupture/trauma/dissection related to the use of the revive se device.No other cerenovus devices were used during the procedure.Section e1 - initial reporter phone: (b)(6).Updated complaint conclusion: as reported via the revive se pms japan study (patient (b)(6)), during a thrombectomy of an occlusion in the middle cerebral artery (distal m1 segment) of the internal carotid artery, a 4.5mm revive se thrombectomy device (frs21452299/t10084) was deployed four times at the target lesion but the thrombus could not be removed.Thrombolysis in cerebral infarction (tici) score of 2a was obtained.A competitor device was deployed once at the site of the occlusion and tici score of 2b was achieved.Prior to the index procedure, the patient¿s alberta stroke program early ct score (aspects) was 10, aspects-dwi score was 5, nihss score was 15, and tici score was 0.The patient initially presented with an acute stage cerebral infarction on (b)(6) 2016.The site of the occlusion was heavily tortuous.There was reportedly no stenosis proximal to the occlusion.Tissue plasminogen (tpa) was administered without success.A 9f cello guiding catheter, marksman (medtronic) microcatheter, and penumbra thrombectomy device were also used in the case.Additional information received indicated that no intraprocedural adverse events/product malfunctions occurred.There was no evidence of vessel damage/rupture/trauma/dissection related to the use of the revive se device.No other cerenovus devices were used during the procedure.No further information was provided.The revive se was not returned for investigation.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.Continued total occlusion is a known potential complication associated with the use of the revive se.The event narrative indicates that the site of the occlusion was heavily tortuous.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 root cause of the event cannot be conclusively determined; however, patient and procedural factors may have contributed to the event.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: REVIVE SE 4.5MM OUS
• Type of Device: EMBOLECTOMY CATHETER
• Manufacturer (Section D): REFER TO SECTION H10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7475115
• MDR Text Key: 107697929
• Report Number: 3008114965-2018-00613
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: FRS21452299
• Device Lot Number: T10084
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 49