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

Catalog Number CDS0502

Device Problem Incomplete Coaptation (2507)

Patient Problems Mitral Regurgitation (1964); Respiratory Distress (2045); Tissue Damage (2104); Heart Failure (2206)

Event Date 09/14/2020

Event Type  Injury  

Manufacturer Narrative

The clip remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This filed to report single leaflet device attachment/slda, tissue damage, worsening mitral regurgitation, heart failure, respiratory distress, prolonged hospitalization, and surgical intervention.It was reported that this was a mitraclip procedure to functional mitral regurgitation (mr) with a grade of 3-4.It was noted restricted posterior mitral leaflet.On (b)(6) 2020, two clips were implanted, reducing mr to 1.Then on (b)(6) 2020, the patient experienced respiratory distress and heart failure symptoms.Imaging showed the second clip was detached from the anterior leaflet but remained attached to the posterior leaflet (single leaflet device attachment/slda), worsening mr to 4.The other clip was stable on both leaflets.The physician stated the cause of the slda was due to the tearing of the anterior leaflet.The patient remained hospitalized.On (b)(6) 2020, the patient underwent mitral valve replacement for additional treatment.The surgery was successful and the patient is stable.There were no adverse patient effects and 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 this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The investigation determined the reported single leaflet device attachment/slda appears to be related to the tissue damage (tearing of the anterior leaflet).The reported worsening mitral regurgitation (mr), respiratory distress, and heart failure appear to be due to the procedural condition of the slda.A cause for the tissue damage cannot be determined.Worsening mitral regurgitation (mr), tissue damage, respiratory distress, and heart failure are listed in the instructions for use as known possible complications associated with mitraclip procedures.The reported hospitalization and surgical procedure were results of case specific circumstance.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10608422
• MDR Text Key: 209237982
• Report Number: 2024168-2020-08136
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 11/13/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2021
• Device Catalogue Number: CDS0502
• Device Lot Number: 00402U240
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 09/30/2020
• Supplement Dates Manufacturer Received: 11/09/2020
• Supplement Dates FDA Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1 IMPLANTED MITRACLIP; 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 52 YR
• Patient Weight: 84