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

Catalog Number CDS0706-NTW

Device Problem Incomplete Coaptation (2507)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2024

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

It was reported that a patient presented with grade unknown mitral regurgitation for a mitraclip procedure.One clip was implanted and the mr reduced.At some point, a single leaflet device attachment occurred.

Event Description

It was reported that a patient presented with grade unknown mitral regurgitation for a mitraclip procedure.One clip was implanted and the mr reduced.At some point, a single leaflet device attachment occurred.Subsequent to the initial report.It was reported that a patient presented with grade 3+ functional mitral regurgitation, mitral annular calcification (mac), severely dilated left atrium, and short leaflets for a mitraclip procedure.The patient's comorbidities are aortic valve stenosis, atrial fibrillation, hypertension, hyperlipidemia, obstructive sleep apnea (osa) and chronic obstructive pulmonary disease (copd).It was noted that imaging was challenging and the procedure was almost discontinued.The clip was able to be visualized and leaflet insertion was satisfactory.One clip was implanted and the mr was reduced to grade 1-2+ a single leaflet device attachment (slda) was observed on (b)(6) 2024 when a patient was admitted for left atrial appendage occlusion (laao) procedure.The mr was unchanged (grade 1-2+) and the clip was stable on one leaflet despite the slda.Per the physician, the patient has severe copd and also was found to have large pleural effusion which needed to be tapped.Symptoms were much improved after thoracentesis and the physician did not attribute the symptoms to the mitraclip or slda.There were no adverse patient effects caused by the mitraclip.

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.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information, the cause of the reported slda and difficult imaging were unable to be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)
• 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: 18695801
• MDR Text Key: 335935864
• Report Number: 2135147-2024-00627
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037435
• UDI-Public: 05415067037435
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2024
• Device Catalogue Number: CDS0706-NTW
• Device Lot Number: 30427R2025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2024
• Supplement Dates Manufacturer Received: 02/29/2024
• Supplement Dates FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2023
• 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 Age: 88 YR
• Patient Sex: Male