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 Angina (1710); Bradycardia (1751); Dyspnea (1816); Fatigue (1849); High Blood Pressure/ Hypertension (1908); Myocardial Infarction (1969); Pulmonary Edema (2020); Renal Failure (2041); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 10/18/2021

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 conservatively filed due to worsening heart failure, pulmonary hypertension, and worsening renal failure, unknown if device related.Patient id: (b)(6).It was reported that on (b)(6) 2021, the patient presented with severe mitral regurgitation.One mitraclip was implanted at the a2p2, reducing the mr to moderate.There was no device deficiency.Starting on (b)(6) 2021, the patient had worsening congestive heart failure with symptoms of weakness, and pulmonary edema noted.Medications were provided.Following an av-node ablation procedure, an acute kidney injury with worsening renal failure was noted.Medications metabolized by the kidneys were placed on hold.On (b)(6) 2022, the patient presented to the emergency room with dyspnea and chest discomfort, worsening congestive heart failure was diagnosed.Medications were provided.On (b)(6) 2022, pulmonary hypertension was noted.The systolic pulmonary artery pressure as 69mmhg.The patient continues to have dyspnea.A follow-up echocardiogram was performed with no device malfunction noted.The events are unknown if device related.There was no device malfunction specified.

Event Description

Subsequent to the previous report, the additional information was received: on (b)(6) 2022, the patient was hospitalized with chest and back pain, unknown if device related.There remains no device malfunction 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.Based on available information, the cause of the reported heart failure, dyspnea, chest pain (angina), pulmonary edema, hypertension, renal failure, and fatigue were unable to be determined.The reported patient effect of heart failure, dyspnea, chest pain (angina), pulmonary edema, hypertension, and renal failure, 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.

Event Description

Subsequent to the previous report, the additional information was received: on (b)(6) 2022, a myocardial infarction was diagnosed.Medications had been provided.The event resolved with improvement in hydration, and the patient was discharged from the hospital.On (b)(6) 2022, the patient presented with bradycardia, elevated troponin, electrocardiogram changes, and an mi was diagnosed in the setting of bacteremia and heart failure.Medications were provided.

Manufacturer Narrative

The device remains implanted and 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 myocardial infarction was unable to be determined.The reported bradycardia was a cascading effect of the reported myocardial infarction.The reported patient effects of myocardial infarction and bradycardia, 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 remains no indication of a product quality issue with respect to manufacture, design or labeling.

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 worsening tricuspid regurgitation (tr) was unable to be determined.The reported patient effect of worsening tr, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.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 received: during admission for chest pain, severe tricuspid regurgitation was noted.

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) was unable to be determined.The reported patient effect of recurrent mr, as listed in the mitraclip system instructions for use, is a known possible complications associated with mitraclip procedures.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 received: during admission for chest pain, recurrent mitral regurgitation was noted as device related.Pulmonary hypertension and mild left ventricular hypertrophy and an enlarged right ventricle were noted.Reportedly, the clip remained well seated.There was no device malfunction.

• 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: 15713887
• MDR Text Key: 302834195
• Report Number: 2135147-2022-01882
• 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,Followup,Followup,Followup,Followup
• Report Date: 07/07/2023

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: 03/16/2022
• Device Model Number: CDS0701-NTW
• Device Catalogue Number: CDS0701-NTW
• Device Lot Number: 10317R165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2022
• Initial Date FDA Received: 11/02/2022
• Supplement Dates Manufacturer Received: 11/29/2022; 01/16/2023; 04/24/2023; 06/20/2023
• Supplement Dates FDA Received: 12/15/2022; 02/07/2023; 05/09/2023; 07/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2021
• 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; Disability; Hospitalization
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 91 KG