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

Model Number CDS0701-XTW

Device Problem Insufficient Information (3190)

Patient Problems Atrial Fibrillation (1729); Atrial Flutter (1730); Dyspnea (1816); Mitral Valve Stenosis (1965); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 04/12/2022

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 mitral stenosis, recurrent mitral regurgitation, and a possible device malfunction.Crd_1002 - expand g4 phase 1 and phase 2 study patient id: (b)(6).It was reported that on (b)(6) 2022, the patient resented with functional mitral regurgitation (mr) grade 4+, with anterior leaflet prolapse and flail.Two mitraclips were implanted without a device deficiency, reducing the mr to grade 1+.On (b)(6) 2022, atrial fibrillation and flutter were noted, treated with medications.On (b)(6) 2022, mitral valve stenosis was noted, treated with medications.On (b)(6) 2023, severe mr was noted and an unspecified device issue occurred with one mitraclip (cds0701-xtw, 10915r152).No additional information was provided regarding the device malfunction or issue.On (b)(6) 2023, the patient had progression of shortness of breath and recurrent mr.Treatment included medications.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.Based on the available information the cause of the reported atrial fibrillation, mitral regurgitation (mr), dyspnea, mitral stenosis (ms), and atrial flutter cannot be determined.The cause of the reported device issue cannot be determined as sufficient information hasn¿t been provided by the account.Additionally, the reported patient effects of mitral regurgitation, dyspnea, and mitral stenosis are listed in the instructions for use and are known possible complications associated with mitraclip procedures.The reported medication required was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

Crd_1002 - expand g4 phase 1 and phase 2 study patient id: (b)(6) it was reported that on (b)(6)2022, the patient resented with functional mitral regurgitation (mr) grade 4+, with anterior leaflet prolapse and flail.Two mitraclips ((b)(6), (b)(6)and (b)(6)) were implanted without a device deficiency, reducing the mr to grade 1+.On (b)(6)2022, atrial fibrillation and flutter were noted, treated with medications.On (b)(6)2022, mitral valve stenosis was noted, treated with medications.On (b)(6)2023, severe mr was noted, and an unspecified device issue occurred with one mitraclip ((b)(6), (b)(6)).No additional information was provided regarding the device malfunction or issue.No malfunction was specified.On (b)(6)2023, the patient had progression of shortness of breath and recurrent mr.Treatment included medications.Subsequent to the previously filed reports, the additional information was received: on (b)(6)2023 another mitraclip was implanted as treatment.There were no complications reported.

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.Based on the available information the cause of the reported atrial fibrillation, mr, dyspnea, ms and atrial flutter cannot be determined.The cause of the reported device issue cannot be determined as sufficient information hasn¿t been provided by the account.Additionally, the reported patient effects of mitral regurgitation, dyspnea, and mitral stenosis are listed in the instructions for use and are known possible complications associated with mitraclip procedures.The reported medication required, unexpected medical intervention and hospitalization were a result 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 (MDD)
• 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: 17143356
• MDR Text Key: 317312918
• Report Number: 2135147-2023-02616
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• 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,Followup
• Report Date: 03/22/2024

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: 09/14/2022
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 10915R152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2023
• Initial Date FDA Received: 06/16/2023
• Supplement Dates Manufacturer Received: 07/07/2023; 03/05/2024
• Supplement Dates FDA Received: 07/24/2023; 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2021
• 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
• Treatment: 1 IMPLANTED MITRACLIP.
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 58 KG