MAUDE Adverse Event Report: MICRUS ENDOVASCULAR, LLC REVIVE - THROMBECTOMY DEVICE; MICRUS THROMBECTOMY

Catalog Number FRS214522C

Device Problem Use of Device Problem (1670)

Patient Problem Intracranial Hemorrhage (1891)

Event Date 03/03/2014

Event Type  Injury  

Manufacturer Narrative

Additional information was received on 4/15/2014: it was reported that the revive was able to cross the clot and expand, but failed to retrieve the clot.There was no resistance or interaction with other devices.The revive was withdrawn along with the prowler select microcatheter.Complaint conclusion: as reported via the japan river i study, there was no evidence of recanalization (pre and post procedure tici score 0) following 5 passes with a revive thrombectomy device (frs214522c/t10000) for treatment of right middle cerebral artery (mca) occlusion, and the (b)(6) patient with a history of myocardial infarction, hypertension, hyperlipidemia, diabetes, atrial fibrillation, and chronic cardiac failure later experienced intracranial hemorrhage with brain edema.It was reported that the revive was able to cross the clot and expand, but failed to retrieve the clot.There was no resistance or interaction with other devices, and the revive was withdrawn along with the prowler select microcatheter.Concomitant treatment had included t-pa.No additional treatment was provided for the incomplete blood flow, and no adverse events were observed during the procedure.The following day, brain ct and mri showed asymptomatic intracranial hemorrhage (ich) at the right nucleus basalis (ph1) and brain edema that was treated with glycerol.Baseline nihss score had been 19 and nihss score 24 hour after procedure was 20.Two days after the procedure, a brain ct showed slight developing of brain edema with compression to the right ventricle and 6mm of midline shift.On the third post-procedure day, there was no change to the ich with nihss score of 18.Seven days after the procedure there was no change to brain edema and no worsening of asymptomatic ich, but slight bleeding at cerebral sulci of the parietal lobe.This was treated with 100mg aspirin daily beginning on post-procedure day eight.Twelve days post-procedure, the patient experienced worsening of respiratory status, aphasia, eyes closed with obvious pupil dilation, and weak light reflex, no locomotor activity on the left lower and upper limbs and decreased locomotor activity on the right.Surgical decompression was conducted due to intracranial hemorrhage located in the right mca infarct lesion.The following day, ct showed improvement of midline shift and intracranial hypertension.The patient¿s consciousness level gradually improved, with increased spontaneous respiration and locomotor activity of 4 limbs.According to the investigator, there was no direct relationship of ich to both device and procedure since the ich associated with primary disease may occur with a certain probability regardless of whether treatment was done, and there was no possible evidence of vessel damage cause by the revive.The investigator further stated that the symptomatic ich that occurred on 12 likely developed by administration of aspirin, therefore causal relationship was denied.The device was returned for analysis.The revive passed inspection and functional testing.The basket expanded as designed.No damage was found to the revive system.Without photographic evidence and clarification from the end user, it cannot be determined why the blood flow was not created.In addition, without return of the microcatheter used in the procedure, it cannot be determined if this component contributed to the complaint event.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.The report of the device being ineffective in removing clot could not be confirmed since the device passed functional testing during product analysis.Based on the information received, procedural/handling factors may have contributed to the effectiveness of the device to retrieve clot.Hemorrhage is a known procedural complication associated with use of the revive and is listed in the instructions for use (ifu) as such.However, since there was no evidence of any procedural complications, and the device functioned normally during analysis, the hemorrhage was most likely related to the patient¿s underlying disease and the use of concomitant medications that would promote bleeding.Since there is no evidence that the complaint was related to a design or manufacturing issue, no corrective actions will be taken.

Event Description

As reported via the (b)(4) study, there was no evidence of recanalization (pre and post procedure tici score 0) following 5 passes with a revive thrombectomy device (frs214522c/t10000) for treatment of right middle cerebral artery (mca) occlusion, and the patient later experienced intracranial hemorrhage with brain edema.Concomitant treatment had included t-pa.No additional treatment was provided for the incomplete blood flow, and no adverse events were observed during the procedure.The following day, brain ct and mri showed asymptomatic intracranial hemorrhage (ich) at the right nucleus basalis (ph1) and brain edema that was treated with glycerol.Baseline nihss score had been 19 and nihss score 24 hour after procedure was 20.Two days after the procedure, a brain ct showed slight developing of brain edema with compression to the right ventricle and 6mm of midline shift.On the third post-procedure day, there was no change to the ich with nihss score of 18.Seven days after the procedure, there was no change to brain edema and no worsening of asymptomatic ich, but slight bleeding at cerebral sulci of the parietal lobe.This was treated with 100mg aspirin daily beginning on post-procedure day eight.Twelve days post-procedure the patient experienced worsening of respiratory status, aphasia, eyes closed with obvious pupil dilation, and weak light reflex, no locomotor activity on the left lower and upper limbs and decreased locomotor activity on the right.Surgical decompression was conducted due to intracranial hemorrhage located in the right mca infarct lesion.The following day, ct showed improvement of midline shift and intracranial hypertension.The patient¿s consciousness level gradually improved, with increased spontaneous respiration and locomotor activity of 4 limbs.

Manufacturer Narrative

According to the investigator, there was no direct relationship of ich to both device and procedure since the ich associated with primary disease may occur with a certain probability regardless of whether treatment was done, and there was no possible evidence of vessel damage cause by the revive.The investigator further stated that the symptomatic ich that occurred on 12 likely developed by administration of aspirin, therefore causal relationship was denied.(b)(6).Additional information will be submitted within 30 days of receipt.The revive passed inspection and functional testing.The basket expanded as designed.No damage was found to the revive system.Without photographic evidence and clarification from the end user, it cannot be determined why the blood flow was not created.In addition, without the identification or the return of the unknown microcatheter used in the procedure, it cannot be determined if this component contributed to the complaint event.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.

Manufacturer Narrative

Revive se product is not distributed in the us; however, it is similar to us distributed revive pv.

• Brand Name: REVIVE - THROMBECTOMY DEVICE
• Type of Device: MICRUS THROMBECTOMY
• Manufacturer (Section D): MICRUS ENDOVASCULAR, LLC; 821 fox lane; san jose CA 95131
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014
• MDR Report Key: 3723734
• MDR Text Key: 11840187
• Report Number: 1226348-2014-00085
• 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,Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FRS214522C
• Device Lot Number: T10000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: T-PA
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 79 YR