MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP G4 CLIP DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

Catalog Number CDS0705-NT

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

Patient Problems Anemia (1706); Hemolysis (1886)

Event Date 02/10/2021

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 hemolysis, hospitalization.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (dmr) with a grade of 4.Two clip delivery systems (cds) were advanced to the mitral valve, noted significant prolapse of posterior leaflet.The clips were implanted, reducing mr to 3.No issues were noted with either cds during use.On (b)(6) 2021, the patient experienced hemolytic anemia.Follow up was performed and the patient was hospitalized.No other treatment was performed.There was no clinically significant delay in the procedure.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 event.Based on available information, a cause for the reported hemolysis and anemia could not be determined.Additionally, hemolysis and anemia are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.The reported hospitalization or prolonged hospitalization was the result of case-specific circumstances.There is no indication of product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11448473
• MDR Text Key: 238821348
• Report Number: 2024168-2021-01879
• 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: 03/29/2021

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: 08/16/2021
• Device Catalogue Number: CDS0705-NT
• Device Lot Number: 00815U273
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2021
• Initial Date FDA Received: 03/09/2021
• Supplement Dates Manufacturer Received: 03/10/2021
• Supplement Dates FDA Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CDS0705-NT 01009U259
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 87 YR
• Patient Weight: 32