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

Catalog Number CDS0702-NT

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

Patient Problems Heart Failure/Congestive Heart Failure (4446); Swelling/ Edema (4577); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.

Event Description

This report is being filed due to worsening heart failure, requiring hospitalization.Crd_1002 - expand g4 phase 1 and phase 2 study.Patient id: (b)(6).It was reported that on (b)(6) 2021, the patient presented with severe degenerative mitral regurgitation (mr) with posterior leaflet flail, mitral leaflet calcification, large coaptation depth, and a small mitral valve area.One mitraclip was implanted, reducing the mr to grade 1+.There was no device deficiency.On (b)(6) 2023, the patient was admitted to the hospital with cardiac decompensation, diagnosed as heart failure, and edema.Per physician, the event was unknown if device related.The patient has been discharged from the hospital.No additional information was provided regarding this issue.

Event Description

Subsequent to the previous report, the additional downgrading information was received: per physician, the heart failure event was unrelated to the mitraclip device.The clip remained seated without any device malfunction reported.Medications had been provided as treatment.This was additional, downgrading information, however, since an initial mdr was already filed, the event had to remain reportable.

Manufacturer Narrative

Additional information was received reporting the events as unrelated to the device.Although this would be downgraded to a non-complaint, since an initial report was already filed, the event remained reportable.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 clip delivery system.There is no indication of a product quality issue with respect to manufacture, design, or labeling.B2: hospitalization removed.B3: date of event corrected to 09-feb-2023.H6: health effect ¿ clinical codes 4446 and 4577 removed.Health effect ¿ impact code 4607 removed.Medical device problem code 2993 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: 16912252
• MDR Text Key: 315013333
• Report Number: 2135147-2023-02052
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/26/2023

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: 05/20/2022
• Device Catalogue Number: CDS0702-NT
• Device Lot Number: 10520R244
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2023
• Initial Date FDA Received: 05/11/2023
• Supplement Dates Manufacturer Received: 05/17/2023
• Supplement Dates FDA Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2021
• 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
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 72 KG