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

Model Number CDS0701-NTW

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

Patient Problems Dyspnea (1816); Hypoxia (1918); Pleural Effusion (2010); Pulmonary Edema (2020); Respiratory Failure (2484); Heart Failure/Congestive Heart Failure (4446); Swelling/ Edema (4577)

Event Date 01/02/2023

Event Type  Injury  

Manufacturer Narrative

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 worsening heart failure and respiratory failure, unknown if device related.Patient: (b)(6).It was reported that on (b)(6) 2021, the patient presented with mixed mitral regurgitation (mr) with hypertrophic cardiomyopathy, posterior leaflet prolapse.One mitraclip was implanted, reducing the mr to grade 2+.There was no device deficiency.On (b)(6) 2023, the patient was admitted to the hospital with dyspnea, hypoxia, lower extremity edema, and worsening congestive heart failure along with acute respiratory failure were diagnosed.The patient had been on home oxygen and has a history of chronic obstructive pulmonary disease.Pulmonary edema along with a pleural effusion were noted.Medications and a bipap machine were provided as treatment.Per physician, the event was unknown if device related.There was no device malfunction.No additional information was provided regarding this issue.

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, the cause for the reported dyspnea, hypoxia, lower extremity edema, congestive heart failure, respiratory failure, pulmonary edema and pleural effusion could not be determined.The reported patient effects of dyspnea, edema, heart failure, and respiratory failure as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.The reported medication required, hospitalization and unexpected medical intervention were results of case-specific circumstances.There is no indication of a product quality 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 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: 16264762
• MDR Text Key: 308380077
• Report Number: 2135147-2023-00320
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230967
• UDI-Public: 08717648230967
• 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: 03/13/2023

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: 04/27/2022
• Device Model Number: CDS0701-NTW
• Device Catalogue Number: CDS0701-NTW
• Device Lot Number: 10427R234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2023
• Initial Date FDA Received: 01/30/2023
• Supplement Dates Manufacturer Received: 02/21/2023
• Supplement Dates FDA Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2021
• 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: 80 YR
• Patient Sex: Male
• Patient Weight: 113 KG