MAUDE Adverse Event Report: MICROVENTION, INC. COSMOS 10 ADVANCED; EMBOLIZATION COIL

Model Number 8210-0722

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Difficult to Remove (1528)

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

Event Date 05/01/2017

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.The device has been returned to the manufacturer.The investigation is currently underway.

Event Description

It was reported that coil embolization was performed on a previously coiled basilar tip aneurysm.After multiple attempts were made to place the 3rd coil, the coil detached when the pusher wire was being removed, leaving approximately 2/3 of the coil in the basilar artery.The detached coil was successfully removed from the coil mass with a snare device.There was no reported patient injury.The patient was reported to be okay post-procedure.

Manufacturer Narrative

The reported cosmos 7x22 implant coil was returned with the snare.The coil was completely stretched from the proximal tie knot location, and was noted to be broken and detached from the marker band.The monofilament was broken.The broken end appeared to be necked down and was noted to have striations indicative of a stretch.The pusher had a resistance value within specification at 41.6 ohms and 46.7 ohms.All four (4) solder joints were noted to be intact.The distal black pet had no evidence of thermal damage.The severed end of the monofilament did look stretched and slit in between, which indicated a tensile break.Based on the investigation and provided information, the complaint of a broken coil can be confirmed.The specific root cause of this complaint is unknown, although the device exhibits evidence that it was subjected to tensile forces that exceeded the strength specifications of the attachment tether.

• Brand Name: COSMOS 10 ADVANCED
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• Manufacturer Contact: debby callahan ; 1311 valencia avenue; tustin, CA 92780
• MDR Report Key: 6601374
• MDR Text Key: 76301025
• Report Number: 2032493-2017-00124
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090891
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/20/2020
• Device Model Number: 8210-0722
• Device Lot Number: 150820GC1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2015
• Is the Device Single Use?: Yes
• 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: 48 YR