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

Catalog Number CDS0705-NTW

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

Patient Problems Arrhythmia (1721); Atrial Fibrillation (1729); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/20/2022

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record identified 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 arrhythmia and atrial fibrillation cannot be determined.The reported mitral regurgitation is related to patient conditions.Mitral regurgitation, arrhythmia and atrial fibrillation are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Serious injury/illness/impairment was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

This report is being filed due to cardiac arrhythmias requiring future hospitalization and treatment.Patient id: (b)(6).It was reported that on (b)(6) 2021, the patient presented with functional mitral regurgitation (mr), with pure annular dilation, mitral annular calcification.One mitraclip was implanted, reducing the mr to grade 1+.There was no device deficiency.On (b)(6) 2022, a follow-up was performed.Atrial tachycardia along with atrial fibrillation were noted, unknown if device related.Future treatment (ablation) with hospitalization is considered necessary.That same day, a slight increase in mr was noted from the previous echocardiogram, from trace to trace/grade 1+.Per physician, the increase in mr was unrelated to the mitraclip device.There was no tissue injury noted, and no malfunction.No additional information was provided regarding this issue.

Event Description

Subsequent to the previous report, the additional, downgrading information was received: on (b)(6) 2023, the patient was hospitalized for the previously reported atrial fibrillation and tachycardia.Ablation was performed as treatment.Per physician, the cardiac arrythmia events, and treatment of, were unrelated to the mitraclip device.The mitraclip remained stable and well seated, without any device related tissue injury.There was no device malfunction.Although this is considered a non-complaint, regulatory reports have already been filed therefore, this will remain reportable.

Manufacturer Narrative

Subsequent information was obtained that the reported arrhythmia and atrial fibrillation were unrelated to the device, therefore, these codes were removed.However, since the initial report has already been filed, the event cannot be downgraded.The reported mitral regurgitation, however, is related to patient conditions.Mitral regurgitation is listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.There remains no indication of a product issue with respect to manufacture, design or labeling.H6 health effect - clinical code 1721 and 1729 were removed, h6 health effect - impact code 4614 was removed, h6 medical device problem code 2993 was removed, h6 investigation conclusions code 67 was removed.

• 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: 16437213
• MDR Text Key: 310169015
• Report Number: 2135147-2023-00660
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/03/2023

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: 02/11/2022
• Device Catalogue Number: CDS0705-NTW
• Device Lot Number: 10210U293
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2023
• Initial Date FDA Received: 02/24/2023
• Supplement Dates Manufacturer Received: 03/09/2023
• Supplement Dates FDA Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2021
• 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): Other
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 50 KG