MAUDE Adverse Event Report: SEE H10 REVIVE SE 4.5MM OUS; EMBOLECTOMY CATHETER

Catalog Number FRS21452299

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Infarction, Cerebral (1771); Infarction, Cerebral (1771); Death (1802); Intracranial Hemorrhage (1891); Intracranial Hemorrhage (1891); No Code Available (3191); No Code Available (3191)

Event Date 01/05/2018

Event Type  Death  

Manufacturer Narrative

Product complaint # (b)(4).Manufacturer name: (b)(4).Physical manufacturer: (b)(4).The name of the initial reporter is unknown.The manufacturer representative was provided as the initial reporter name.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported via the revive se pms japan study, the patient (b)(6) expired due to brain stem infarction.The patient had presented with acute cerebral infarction and thrombectomy was performed on (b)(6) 2018.During the procedure, the patient developed symptomatic intracranial hemorrhage (ph2) at the occluded blood vessel site with symptoms of consciousness disturbance.The revive se was deployed once, but bleeding occurred during the revascularization procedure with use of a concomitant device and recanalization of the infarct site could not be obtained.The patient expired on (b)(6) 2018 due to brain stem infarction.The revive se thrombectomy device (frs21452299/s12511) was not available for investigation.The revive se product was not returned for investigation, but the lot number has been identified.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 root cause of the event could not be conclusively determined; however, procedural/patient factors may have contributed to the event.It appears that the procedure may have been terminated prior to completion of the procedure due to the intracranial hemorrhage.Hemorrhage and stroke are known potential complications associated with the revive se.The root cause of the event could not be determined; however, patient and pharmacologic factors may have contributed to the event.The patient had presented with neurological symptoms.As reported, the hemorrhage may have been associated with a concomitant device.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.

Event Description

As reported via the se pms japan study (patient (b)(6)), the patient expired.The revive se thrombectomy device (frs21452299, unknown lot number) is not available for investigation.The details are unknown.Additional information received indicated that the patient expired due to brain stem infarction.The patient had presented with acute cerebral infarction and thrombectomy was performed on (b)(6) 2018.During the procedure, the patient developed symptomatic intracranial hemorrhage (ph2) at the occluded blood vessel site with symptoms of consciousness disturbance.The revive se was deployed once, but bleeding occurred during the revascularization procedure with use of a concomitant device and recanalization of the infarct site could not be obtained.The patient expired on (b)(6) 2018 due to brain stem infarction.The revive se thrombectomy device (frs21452299/s12511) was not available for investigation.

Manufacturer Narrative

(b)(4).Complaint conclusion updated with additional information: as reported via the revive se pms (b)(6) study, the patient 312-06, with a history of cerebral infarction, hypertension, and previous endovascular treatment, expired due to brain stem infarction as a result of intraprocedural hemorrhage.The patient had presented with acute cerebral infarction accompanied by obstruction of the midline basilar artery of the vertebral basilar artery, with mrs 3, and thrombectomy was performed on (b)(6) 2018.Before the procedure, aspects-ct was 10 points, aspects-dw was: 11 points, nihss was 33 points, and tici was 0.There was mildly tortuousness at the occluded site and there was no stenosis at proximal portion from the occlusion.The vessel diameter of the treated vessel and the length of the occlusion site were unknown.The t-pa was not applicable.During the procedure, the patient developed symptomatic intracranial hemorrhage (ph2) at the occluded blood vessel site with symptoms of consciousness disturbance.The revive se was deployed once, but bleeding occurred during the revascularization procedure with use of a concomitant device and recanalization of the infarct site could not be obtained.Consciousness disorder remained as a sequelae.Immediately after the procedure, nihss was 36 points.The patient expired on 8 (b)(6) 2018 due to brain stem infarction.The revive se thrombectomy device (frs21452299/(b)(4)) was not available for investigation.The revive se product was not returned for investigation, but the lot number has been identified.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 root cause of the event could not be conclusively determined; however, procedural/patient factors may have contributed to the event.It appears that the procedure may have been terminated prior to completion of the procedure due to the intracranial hemorrhage.Hemorrhage and stroke are known potential complications associated with the revive se.The root cause of the event could not be determined; however, patient and pharmacologic factors may have contributed to the event.The patient had presented with neurological symptoms.As reported, the hemorrhage may have been associated with a concomitant device.This event will be reportable due to the device not being effective in removing thrombus (product malfunction).As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.

Manufacturer Narrative

Product complaint # (b)(4).Manufacturer name: (b)(4).Physical manufacturer: (b)(4).The name of the initial reporter is unknown.The manufacturer representative was provided as the initial reporter name.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported via the revive se pms japan study, the patient (b)(6) expired due to brain stem infarction.The patient had presented with acute cerebral infarction and thrombectomy was performed on (b)(6) 2018.During the procedure, the patient developed symptomatic intracranial hemorrhage (ph2) at the occluded blood vessel site with symptoms of consciousness disturbance.The revive se was deployed once, but bleeding occurred during the revascularization procedure with use of a concomitant device and recanalization of the infarct site could not be obtained.The patient expired on (b)(6) 2018 due to brain stem infarction.The revive se thrombectomy device (frs21452299/s12511) was not available for investigation.The revive se product was not returned for investigation, but the lot number has been identified.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 root cause of the event could not be conclusively determined; however, procedural/patient factors may have contributed to the event.It appears that the procedure may have been terminated prior to completion of the procedure due to the intracranial hemorrhage.Hemorrhage and stroke are known potential complications associated with the revive se.The root cause of the event could not be determined; however, patient and pharmacologic factors may have contributed to the event.The patient had presented with neurological symptoms.As reported, the hemorrhage may have been associated with a concomitant device.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.

Event Description

As reported via the se pms japan study (patient (b)(6)), the patient expired.The revive se thrombectomy device (frs21452299, unknown lot number) is not available for investigation.The details are unknown.Additional information received indicated that the patient expired due to brain stem infarction.The patient had presented with acute cerebral infarction and thrombectomy was performed on (b)(6) 2018.During the procedure, the patient developed symptomatic intracranial hemorrhage (ph2) at the occluded blood vessel site with symptoms of consciousness disturbance.The revive se was deployed once, but bleeding occurred during the revascularization procedure with use of a concomitant device and recanalization of the infarct site could not be obtained.The patient expired on (b)(6) 2018 due to brain stem infarction.The revive se thrombectomy device (frs21452299/s12511) was not available for investigation.

• Brand Name: REVIVE SE 4.5MM OUS
• Type of Device: EMBOLECTOMY CATHETER
• Manufacturer (Section D): SEE H10; 47709 fremont blvd; freemot CA 94538
• Manufacturer (Section G): SEE H10; 47709 fremont blvd; freemont CA 94538
• Manufacturer Contact: gabriel alfageme ; chemin-blanc 38; le locle neuchatel CH-24-00 ; SZ CH-2400 ; 949789-868
• MDR Report Key: 7359598
• MDR Text Key: 103128640
• Report Number: 3008114965-2018-00558
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2018

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: FRS21452299
• Device Lot Number: S12511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/22/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 0
• Patient Outcome(s): Death
• Patient Age: 77 YR
• Patient Weight: 41