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

Catalog Number CDS0705-XTW

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

Patient Problems Mitral Valve Stenosis (1965); Heart Failure/Congestive Heart Failure (4446); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/23/2023

Event Type  Injury  

Event Description

This will be filed to report heart failure and mitral stenosis.It was reported that a patient that previously underwent a mitraclip procedure was diagnosed with mitral stenosis and was hospitalized for heart failure symptoms.No additional information was provided.

Manufacturer Narrative

D4: the udi number is not known as the part and lot numbers were not provided.The clip remains in the patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

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 clip delivery system.Since an initial assessment was already made, the event was will not be voided.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6: codes 4446, 1965, 4607, and 2993 were removed.

Event Description

Subsequent to the previously reported information, it was further reported that on (b)(6) 2023 a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) grade 4.One clip was implanted and the procedure was concluded with a resulting mr of grade 1 and a resulting pressure gradient of 4.It was also noted the patient returned to the hospital with a pressure gradient of 4.In the treating physician's opinion, the mitral stenosis was the cause of the patient's hemodynamic deterioration and subsequent heart failure hospitalization.There was no clinically significant delay in the procedure and no adverse patient sequelae.No additional information was provided.

• 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: 17334484
• MDR Text Key: 319281576
• Report Number: 2135147-2023-03048
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/22/2023

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: 08/03/2023
• Device Catalogue Number: CDS0705-XTW
• Device Lot Number: 20803R1068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2023
• Initial Date FDA Received: 07/17/2023
• Supplement Dates Manufacturer Received: 09/05/2023
• Supplement Dates FDA Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2022
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 68 KG