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

Catalog Number FRS214522C

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/12/2013

Event Type  Injury  

Event Description

The (b)(4) study for patient with (b)(6) indicated that removal of the clot with the revive thrombectomy device (frs214522c/t10000) was unsuccessful and the basket was not seen under fluoroscopy.However, the markers were seen when deploying the basket.Post-revive se angiogram showed tici 0 at m2 artery.Pre-procedural imaging showed mca occlusion, vessel diameter distal/proximal was 2.5 mm, tici 0, and nihss was 16 and 18 after 24 hours.Revive se was used to treat right m1 occlusion.After introduction and deployment, the revive se device was carefully withdrawn.The device contained only a stump of the clot, supported by the post angiogram showing persistent occlusion at m1 region.Therefore, additional two revive se treatments with 7 minutes interval were conducted, but the blood flow did not improve (tici 0).Alternate treatment using penumbra was done, but recanalization was not achieved (tici 0).Since the time to treatment exceeded 5 hours and the risk of hemorrhagic complication increased, the investigator decided to terminate the treatment.All the process was done properly according to the instructions.Positioning of the device was done without any problem, because the procedure was under fluoroscopic.Expansion was unclear because although the markers were seen, the basket could not be seen.The stump end of the clot was collected.The issue was, ¿the revive basket could not been seen under fluoroscopy¿, but the markers are seen.For visualizing the basket during the procedure, they have to take a different imaging, such as corn-beam ct, but this site doesn¿t have this kind of imaging technique.

Manufacturer Narrative

The device was deployed to the target site without any problem.Recanalization was observed while the basket was expanding, but the signal of distal flow gradually decreased as time went along (up to 7 minutes after expansion).Device was drawn back at 10 minutes after expansion, but tici was 0.The investigator said that it was difficult to retrieve the clot because it was so stiff.(b)(6).Complaint conclusion: the device was returned for analysis.The revive passed inspection and functional testing.No damage was found to the revive.Without photographic evidence and clarification from the end user, it cannot be determined why the blood flow was not created.It should be noted that the competitor¿s devices also did not create blood flow.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.The device was returned for analysis and no damages were noted; therefore, the complaint could not be confirmed.Based on the available information, no definitive conclusion can be made.It appears that procedural factors, possibly including device manipulation and device interaction, may have contributed to the reported event, because it was noted that the clot was stiff.Additionally, the event of deployment difficulty was not confirmed, since the device function accordingly and the markers on the basket were seen under fluoroscopy.A review of the manufacturing documentation associated with this lot t10000 presented no issues during the manufacturing process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.Revive se 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 ; 5088283106
• MDR Report Key: 4077818
• MDR Text Key: 4851184
• Report Number: 1226348-2014-00482
• 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: Health Professional
• Type of Report: Initial
• Report Date: 08/16/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: FRS214522C
• Device Lot Number: T10000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 72