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

Catalog Number CDS0702-XTW

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

Patient Problems Endocarditis (1834); Sepsis (2067); Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)

Event Date 10/14/2022

Event Type  Death  

Event Description

This report is being conservatively filed for patient death.Patient id: (b)(6).It was reported that on (b)(6) 2022, the patient presented with functional mitral regurgitation (mr) grade 4+, with mitral annular calcification and leaflet tethering.One mitraclip was implanted, reducing the mr to grade 2+.There was no device deficiency.On (b)(6) 2022, the patient had expired.The cause of death was unknown.Reportedly, additional details are not available at this time.No additional information was provided regarding this issue.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

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.Based on available information, causes for the reported endocarditis, sepsis, and heart failure could not be determined.The reported death appears to be due to worsening patient condition.Additionally, the reported patient effects of death, endocarditis, sepsis, and heart failure are listed in the instructions for use as a known possible complications associated with mitraclip procedures.The reported medication and hospitalization were the results of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.

Event Description

Subsequent to the previous report, the additional information was received: on (b)(6) 2022, the patient had been admitted to the hospital with worsening heart failure, cardiovascular infection, and sepsis.Endocarditis of the mitral valve was noted, treated with medications.A myocardial infarction was also diagnosed, treated with a percutaneous coronary intervention with stent placement.Per physician, the myocardial infarction was unrelated to the mitraclip device.On (b)(6) 2022, the patient had expired.

• 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: 16195008
• MDR Text Key: 307602409
• Report Number: 2135147-2023-00223
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/13/2023

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: 09/28/2022
• Device Catalogue Number: CDS0702-XTW
• Device Lot Number: 10929R179
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2022
• Initial Date FDA Received: 01/18/2023
• Supplement Dates Manufacturer Received: 02/03/2023
• Supplement Dates FDA Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• 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): Death
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 78 KG