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 Intracranial Hemorrhage (1891); Hemorrhage, Subarachnoid (1893); Vascular Dissection (3160)

Event Date 04/25/2018

Event Type  Injury  

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.Information regarding patient weight, medical history, race, and ethnicity was not provided.(b)(4).Concomitant med products due to character limitation: velocity (penumbra) microcatheter, ace 68 (penumbra) reperfusion catheter, 4max (penumbra) aspiration catheter.Initial reporter - the customer contact information, including name, occupation, phone, fax, and e-mail, was not provided.(b)(4).Complaint conclusion: as reported by a healthcare professional, during a thrombectomy of an occlusion in the middle cerebral artery (m2 towards m3 segment), a 4.5 mm revive (frs21452299/s13684) thrombectomy device was deployed using pinch technique, but a dissection/hemorrhage occurred just after withdrawal of the revive.A competitor device (inner lumen 0.041¿) was approached to the lesion to aspirate the clot.The bleeding was stopped by occluding the artery with coils and glue.The patient experienced dysphagia and cognitive behavior deficit.The patient is currently in a rehabilitation facility.The patient¿s modified rankin scale (mrs) will be assessed in three months.A velocity (penumbra) microcatheter and an ace 68 (penumbra) reperfusion catheter were also used in the case.No further information was provided.The revive se was discarded and is thus not available for evaluation.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.Arterial dissection and hemorrhage are known potential complications associated with the revive se.With the amount of information available and without films of the event, it is not possible to draw a clinical conclusion between the device and the reported event.However, it is possible that clinical and procedural factors including vessel characteristics, tortuosity, device selection, and manipulation of devices within the artery are may contributed to the reported event.The patient had presented with an ischemic stroke and likely received thrombolytic treatment during the procedure which could increase the likelihood of developing hemorrhage.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 by a healthcare professional, during a thrombectomy of an occlusion in the middle cerebral artery (m2 towards m3 segment), a 4.5 mm revive (frs21452299/s13684) thrombectomy device was deployed using pinch technique, but a dissection/hemorrhage occurred just after withdrawal of the revive.A competitor device (inner lumen 0.041¿) was approached to the lesion to aspirate the clot.The bleeding was stopped by occluding the artery with coils and glue.The patient experienced dysphagia and cognitive behavior deficit.The patient is currently in a rehabilitation facility.The patient¿s modified rankin scale (mrs) will be assessed in three months.A velocity (penumbra) microcatheter and an ace 68 (penumbra) reperfusion catheter were also used in the case.The product was discarded and is thus not available for return.No further information was provided.

Manufacturer Narrative

Product complaint#: (b)(4).Updated sections: outcomes attributed to adverse event, event, relevant tests/laboratory data, other relevant history, initial reporter name and address, initial reporter health professional, initial reporter occupation, pma/510k, if follow-up, what type.Event: additional information received indicated that computed tomography (ct) brain scan and ct perfusion imaging revealed a subarachnoid hemorrhage.The patient suffered from aphasia and hemiplegia due to the event.The hemorrhage resulted in an extension of the hospital stay and the patient was transferred to a rehabilitation facility on (b)(6) 2018.The patient¿s current health condition is reportedly ¿quite bad¿; residual symptoms include partial motor aphasia.The physician assessed that the device was ¿probably too big¿ for the target vessel.The patient initially presented with a moderate to severe stroke (national institutes of health stroke scale score of 16).The patient subsequently underwent a thrombectomy of an occlusion in the m2 segment of the left middle cerebral artery (mca) with a 4.5mm revive se thrombectomy device (frs21452299/s13684) but the device failed to remove the target thrombus from the treated vessel, prompting the insertion of a competitor device.The occlusion/thrombus was a ¿few¿ millimeters long.There was no report of calcification within the thrombus.The thrombosed vessel was neither tortuous nor stenotic.The percentage of occlusion before the thrombectomy was ¿complete¿.The patient¿s thrombolysis in cerebral infarction (tici) score prior to the case was 2a and remained unchanged after use of the revive se device.The patient¿s status post-procedure was worsened.The patient was on oral anticoagulation pre-procedure; however, the patient¿s activated clotting times (acts) are not available.The patient was not administered tissue plasminogen activator (tpa) prior to the case.The physician did not encounter any difficulty with the revive se during the procedure.There had been resistance during use of the device, but it was not excessive and there were no device performance issues.The device could be advanced distal to the thrombus and was used only once.No other cerenovus devices were used during the case.Initial reporter name and address: (b)(6).Updated complaint conclusion: as reported by a healthcare professional, during thrombectomy of an occlusion in the middle cerebral artery (m2 towards m3 segment), a 4.5mm revive se (frs21452299/s13684) thrombectomy device was deployed using pinch technique, but a dissection/hemorrhage occurred just after withdrawal of the revive se.A competitor device (inner lumen 0.041¿) was approached to the lesion to aspirate the clot.The bleeding was stopped by occluding the artery with coils and glue.The patient experienced dysphagia and cognitive behavior deficit.A velocity (penumbra) microcatheter and an ace 68 (penumbra) reperfusion catheter were also used in the case.Additional information received indicated that computed tomography (ct) brain scan and ct perfusion imaging revealed a subarachnoid hemorrhage.The patient suffered from aphasia and hemiplegia due to the event.Following prolonged hospitalization, the patient was transferred to a rehabilitation facility on (b)(6) 2018 with residual symptoms of partial motor aphasia.The physician assessed that the device was ¿probably too big¿ for the target vessel.The patient initially presented with a moderate to severe ischemic stroke (national institutes of health stroke scale score of 16).The patient subsequently underwent a thrombectomy of an occlusion in the m2 segment of the left middle cerebral artery (mca) with a 4.5mm revive se thrombectomy device (frs21452299/ s13684) but the device failed to remove the target thrombus from the treated vessel, prompting the insertion of a competitor device.The occlusion/thrombus was a ¿few¿ millimeters long.There was no report of calcification within the thrombus.The thrombosed vessel was neither tortuous nor stenotic.The patient¿s thrombolysis in cerebral infarction (tici) score was 2a prior to and after use of the revive se.The patient¿s status post-procedure was worsened.The patient was on oral anticoagulation pre-procedure; however, the patient¿s activated clotting times (acts) are not available.The patient was not administered tissue plasminogen activator (tpa) prior to the case.The physician did not encounter any difficulty with the revive se during the procedure.There had been resistance crossing the target lesion, but it was not excessive and there were no device performance issues.The device could be advanced distal to the thrombus and was used only once.No other cerenovus devices were used during the case.No further information was provided.The revive se was discarded and is thus not available for evaluation.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.Arterial dissection and hemorrhage are known potential complications associated with the revive se.With the amount of information available and without films of the event, it is not possible to draw a clinical conclusion between the device and the reported event.However, it is possible that patient, pharmacological, and procedural factors including vessel characteristics, tortuosity, device selection, and manipulation of devices within the artery may have contributed to the reported event.The physician reported that the device may have been ¿too big¿ for the target vessel.There is no evidence that suggests any type of manufacturing or design issue.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: 7557028
• MDR Text Key: 109661653
• Report Number: 3008114965-2018-00638
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: FRS21452299
• Device Lot Number: S13684
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 72 YR