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

Catalog Number CDS0701-XTW

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

Patient Problems Dyspnea (1816); Hypoxia (1918); Pulmonary Edema (2020); Heart Failure/Congestive Heart Failure (4446)

Event Date 06/23/2023

Event Type  Injury  

Event Description

This report is being filed due to worsening heart failure requiring hospitalization.Crd_1002 - expand g4 phase 1 and phase 2 study patient id: (b)(6) it was reported that on (b)(6) 2021, the patient presented with mixed mitral regurgitation (mr) with mitral annular calcification.One mitraclip (cds0701-xtw, 10721r145) clip was implanted, reducing the mr to grade 1+.There was no device deficiency.On (b)(6) 2023, the patient was hospitalized with shortness of breath for three days.The patient was noted in volume overload, hypoxic, pulmonary edema was observed, and worsening heart failure was diagnosed.Medications were provided as treatment with improvement noted.There was no device malfunction.No additional information was provided regarding this issue.

Manufacturer Narrative

The device was not returned for evaluation.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 the information reviewed, a cause for heart failure/congestive heart failure, pulmonary edema, dyspnea and hypoxia cannot be determined.Dyspnea, heart failure and pulmonary edema are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Medication required and hospitalization were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.Na.

• 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: 17793575
• MDR Text Key: 323978847
• Report Number: 2135147-2023-04130
• 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
• Report Date: 09/21/2023

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: 07/21/2022
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 10721R145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2023
• Initial Date FDA Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• 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): Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 54 KG