MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

Catalog Number SGC0302

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Date 05/14/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the information reviewed, a conclusive cause for the thrombosis could not be determined.The reported patient effect of thrombosis is listed in the mitraclip system instructions for use, as a known possible complication associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional mitraclip device referenced is being filed under a separate medwatch report.

Event Description

This is filed to report thrombosis.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.One clip was successfully implanted.The second clip delivery system (cds) was advanced to the left atrium.While inside the left atrium, thrombus was observed on the tip of the steerable guide catheter (sgc).The cds was removed and aspiration was performed to remove the thrombus from the sgc tip.The cds was carefully examined, cleaned with heparinized saline and re-inserted into the sgg.After the cds reached the left atrium, thrombus immediately formed on the tip of the clip.The clip was not implanted and the cds was removed with the thrombus material.A new cds was used and the clip was implanted and no further thrombus was observed.Three clips were implanted, reducing mr to 1-2.The activated coagulation time (act) fluctuated between 180 to 350 during the procedure despite measuring every 20 minutes, and administering heparin according to normal procedure.No additional information was provided.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: STEERABLE GUIDE CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 8670190
• MDR Text Key: 147043536
• Report Number: 2024168-2019-04416
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 90107U102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2019
• 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
• Treatment: 1 IMPLANTED MITRACLIP, CLIP DELIVERY SYSTEM
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 105