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

Model Number CDS0701-NTW

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Atrial Fibrillation (1729); Dyspnea (1816); Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Mitral Valve Stenosis (1965); Tachycardia (2095); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451); Swelling/ Edema (4577); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/03/2022

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 worsening heart failure, requiring treatment.Patient id: (b)(4).It was reported that on (b)(6) 2021, the patient presented with severe mixed mitral regurgitation (mr) with an anterior leaflet prolapse, mitral annular calcification, leaflet tethering.One mitraclip was implanted, reducing the mr to grade 3+.On (b)(6) 2022, the patient was hospitalized for dyspnea, dry cough, fatigue, weight gain, orthopnea, and worsening congestive heart failure.Medications were provided.Per physician, the event was unknown if device related.There was no device malfunction specified.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 of the reported dyspnea (treatment with medication(s)), fatigue, and heart failure/congestive heart failure (treatment with medication(s)) could not be determined.The reported patient effects of dyspnea and heart 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.

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, there are no related effects to the mitraclip device.Since an initial report was already filed, the event was unable to be downgraded to a non-complaint.There is no indication of a product quality issue with respect to manufacture, design, or labeling.B2: hospitalization and required intervention removed.H6: health effect clinical code ¿ 1816, 4446, 1849 removed.Health effect impact code ¿ 4644, 4607 removed.Medical device problem code ¿ 2993 removed.Investigation conclusion code ¿ 22 removed.

Event Description

Subsequent to the previous report, the additional information was received: per physician, the (b)(6) 2022 heart failure event was unrelated to the device.There was no device malfunction.Although the additional information received would be considered a non-complaint, regulatory reports have already been filed, therefore, the event was unable to be downgraded to a non-complaint.

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 the reported mitral valve insufficiency/regurgitation (mr), dyspnea, hypotension, heart failure/congestive heart failure, mitral stenosis, edema, atrial fibrillation, tachycardia and fatigue cannot be determined.Dyspnea, heart failure, edema, atrial fibrillation, tachycardia, hypotension, mitral regurgitation and mitral stenosis 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.H6: health effect - clinical code 4582 removed.Health effect - impact code 2199 removed.Medical device problem code 3189 removed.

Event Description

Subsequent to the previous report, the additional information was received: on (b)(6)2022, recurrent mitral regurgitation (mr) was observed without any device malfunction.There was no intervention and no unplanned hospitalization provided due to the recurrent mr.On (b)(6)2023, mitral valve stenosis was diagnosed.No treatment was provided for the stenosis.On (b)(6)2023, the patient presented to the emergency room with fatigue and hypotension.Tachycardia was noted along with atrial fibrillation.Elevated troponin was noted and worsening congestive heart failure was diagnosed.Medications along with fluids were provided, and cardioversion was performed as treatment.On(b)(6)2023, the patient presented with shortness of breath and lower extremity edema.Congestive heart failure was diagnosed, treated with medications.There was no device malfunction reported.These heart failure events are unknown if device related.

• 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: 15697180
• MDR Text Key: 302690556
• Report Number: 2135147-2022-01851
• 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
• Report Date: 01/04/2024

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2022
• Device Model Number: CDS0701-NTW
• Device Catalogue Number: CDS0701-NTW
• Device Lot Number: 10608R247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2022
• Initial Date FDA Received: 10/29/2022
• Supplement Dates Manufacturer Received: 12/05/2022; 01/18/2023; 01/03/2024
• Supplement Dates FDA Received: 12/19/2022; 02/07/2023; 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 108 KG