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 08/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the steerable guide catheter was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The mitraclip clip delivery system (cds 80202u119) referenced is filed under separate medwatch report.

Event Description

This event is filed for blood clot in the left atrium.It was reported that the patient underwent a mitraclip procedure, treating degenerative mitral regurgitation of grade 3-4.Patient anatomy included a posterior leaflet prolapse.The steerable guide catheter (sgc) was advanced into the patient anatomy.The clip delivery system was inserted into the anatomy; however, a clot was noted at the tip of the sgc, in the left atrium.The activated clotting time (act) was 280 and an additional 3000 units of heparin were administered.The clot dissolved and the procedure continued with implantation of the clip.Cds (80202u119) was advanced and an attempt was made to grasp the leaflets.Leaflet insertion assessment could not be successfully completed, as the patient anatomy made it visually challenging to see both leaflets inside the clip; however, the clip was deployed.After deployment, it was noted that the clip detached from the anterior leaflet, remaining attached to the posterior leaflet.An additional clip was implanted medial to the second implanted clip (80202u119) to stabilize the detached clip.The mr was reduced to grade 2-3.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.The reported patient effect of emboli (thrombus), as listed in the mitraclip system instructions for use is a known possible complication associated with mitraclip procedures.Based on the information reviewed, a definitive cause for the reported thrombus could not be determined.Although a conclusive cause for the reported patient effect of thrombosis and the relationship to the device, if any, cannot be determined based on the reported information, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 7883363
• MDR Text Key: 120520065
• Report Number: 2024168-2018-07233
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80201U236
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2018
• 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