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

Model Number CDS0701-NT

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

Patient Problems Bradycardia (1751); Dyspnea (1816); Hypoxia (1918); Mitral Valve Stenosis (1965); Pleural Effusion (2010); Pulmonary Edema (2020); Respiratory Failure (2484); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451); Swelling/ Edema (4577)

Event Date 07/23/2022

Event Type  Injury  

Manufacturer Narrative

The device was implanted and will not return 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 recurrent mitral regurgitation and mitral stenosis.Patient id: (b)(6).It was reported that on (b)(6) 2021, the patient presented with ischemic, mixed mitral regurgitation (mr) grade 4+, with leaflet tethering and prolapse.Two mitraclips were successfully implanted, reducing the mr to grade 1+.On (b)(6) 2022, severe mitral valve stenosis with a pressure halftime of 0.61 cm2, mean mitral valve gradient of 14mmhg and recurrent mr was observed.The clips remained stable without a device malfunction.On (b)(6) 2022, another echocardiogram was performed.Severe mr with three distinct jets, the dominant jet is a posteromedial jet.The severe mitral valve gradient remained.No treatment was provided.

Event Description

Subsequent to the previous report, the additional information was obtained: on (b)(6) 2022, during hospitalization for heart failure, recurrent mitral regurgitation (mr) was noted.On (b)(6) 2022, the patient presented with the emergency room with worsening dyspnea, lower extremity edema, bradycardic, elevated bnp, and worsening congestive heart failure was diagnosed.A chest x-ray was performed with mild pulmonary edema, and mild pleural effusions observed.Medications were provided as treatment.There was no hospitalization.

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 of the reported recurrent mitral regurgitation (mr) and mitral stenosis could not be determined.The reported dyspnea, lower extremity edema, congestive heart failure, pulmonary edema, pleural effusion and sinus bradycardia were due to worsening of existing condition.The reported patient effects of mitral stenosis, mr, dyspnea, edema, heart failure and cardiac arrhythmias as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.The reported medication required and hospitalization were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: health effect ¿ impact code 4614 removed.

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.A cause of the reported respiratory failure could not be determined.The reported hypoxia was related to the respiratory failure.The reported patient effect of respiratory failure, as listed in the mitraclip system instructions for use, is a known possible complications associated with mitraclip procedures.The reported unexpected medical intervention and surgical intervention were results of case-specific circumstances.There remains no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the previous report, the additional information was obtained: on (b)(6) 2023, the patient had been hospitalized for acute respiratory failure with hypoxia.The patients oxygen saturations 88-89% on room air.Pulmonary edema, pulmonary effusions with atelectasis were noted.As treatment, oxygen was provided.On (b)(6) 2023, a mitral valve replacement was performed.

• 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: 15779843
• MDR Text Key: 303558997
• Report Number: 2135147-2022-02041
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230943
• UDI-Public: 08717648230943
• 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: 12/01/2023

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: 02/26/2022
• Device Model Number: CDS0701-NT
• Device Catalogue Number: CDS0701-NT
• Device Lot Number: 10226R122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 11/11/2022
• Supplement Dates Manufacturer Received: 11/18/2022; 11/27/2023
• Supplement Dates FDA Received: 12/12/2022; 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2021
• 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; Other; Disability; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 86 KG