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

Catalog Number CDS0704-XTW

Device Problem Incomplete Coaptation (2507)

Patient Problems Dyspnea (1816); Fatigue (1849); Hemolysis (1886); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 09/13/2022

Event Type  Injury  

Manufacturer Narrative

The device is not returning for analysis.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This report is being filed due to a single leaflet device attachment, recurrent mitral regurgitation, and hemolysis, requiring intervention.Patient id: (b)(6).It was reported that on (b)(6) 2022, the patient presented with degenerative mitral regurgitation (mr) grade 4+, with flail and chordal rupture.Two mitraclips were successfully implanted, reducing the mr to grade 1+.On (b)(6) 2022, the patient presented with shortness of breath and fatigue.A follow-up echocardiogram was performed.The mr had increased to severe, grade 4+ with an eccentric jet and single leaflet device attachment (slda) noted with one of the two mitraclips (cds0704-xtw 20120r114).The patient was hospitalized.Additional labs were performed, low haptoglobin and elevated bilirubin were noted, hemolysis was diagnosed, associated with the clip.On (b)(6) 2022, a mitral valve replacement was performed, removing the clips.No additional information was provided regarding this issue.

Manufacturer Narrative

All available information was investigated, and the reported single leaflet device attachment (slda) was not confirmed via device analysis.A bent gripper and a cut gripper were observed via device 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 incidents reported from this lot.Based on available information, the cause of the reported dyspnea, mitral regurgitation (mr), fatigue, and hemolysis (surgical treatment (device removal)) appear to be due to the slda.The cause of the reported slda could not be determined.The cause of the observed deformation due to compressive stress associated with the bent gripper, and the observed material split, cut or torn associated with the cut gripper are due to the removal process during valve replacement surgery.The reported patient effects of dyspnea and mr, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported hospitalization and surgical intervention were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

Subsequent to the previous report, additional information was obtained: on (b)(6) 2022, the pre-procedure functional and degenerative mitral regurgitation (mr) was 4 and had been reduced to grade 2.Another mitraclip procedure was not performed.On (b)(6) 2022, diagnostic right heart and left heart catheterization procedures were performed.On (b)(6) 2022, a mitral valve replacement was performed, removing the implanted clips.No additional information was provided.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15556514
• MDR Text Key: 301343115
• Report Number: 2135147-2022-01515
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/28/2022

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: 01/23/2023
• Device Catalogue Number: CDS0704-XTW
• Device Lot Number: 20120R114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2022
• Initial Date FDA Received: 10/06/2022
• Supplement Dates Manufacturer Received: 12/08/2022
• Supplement Dates FDA Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/24/2022
• 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.
• Patient Outcome(s): Disability; Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White