MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP XTR CLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number CDS0602-XTR

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

Patient Problem Thrombosis (2100)

Event Date 12/17/2020

Event Type  Injury  

Manufacturer Narrative

The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report thrombosis.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.When advancing the transseptal sheath and needle, the tip of the needle slipped and may have scratched a posterior wall of the ra, causing the pericardial effusion.It was noted that neither of the devices worsened the pericardial effusion.The steerable guide catheter (sgc) and clip were inserted into the left atrium (la), but it was observed through echocardiography that thrombus was on the wall of the la.For treatment, 3000 additional units of heparin were administered.It was noted that the activated clotting time was greater than 250 throughout the procedure.The patient¿s vital signs remained stable; therefore, the physician decided to resume with the procedure.The clip was successfully implanted, reducing mr to a grade of 1.No additional clips were implanted, but it was noted that the after the procedure was completed, thrombus remained in the la.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported issue.Based on the information reviewed, the reported thrombus was a result of procedural conditions.Thrombus, as listed in the mitraclip instructions for use, is a known possible complication associated with mitraclip procedures.The treatment with medication was a result of case-specific circumstances as additional heparin was administered to treat the thrombus.There is no indication of a product issue with respect to manufacture, design or labeling.Na.

• Brand Name: MITRACLIP XTR CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11131743
• MDR Text Key: 225527216
• Report Number: 2024168-2021-00196
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2021
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 00729U187
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 01/07/2021
• Supplement Dates Manufacturer Received: 02/03/2021
• Supplement Dates FDA Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 90