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

Catalog Number CDS0705-NTW

Device Problems Improper or Incorrect Procedure or Method (2017); Incomplete Coaptation (2507)

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

Event Date 01/11/2024

Event Type  Injury  

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 reported slda was due to a combination of procedural circumstances and challenging patient anatomy.The difficult imaging was due to challenging patient anatomy.The reported unexpected medical intervention was a result of case-specific circumstances.The reported improper or incorrect procedure or method was due to the user deploying while leaflet coaptation and insertion was not satisfactory in all views.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

It was reported that a mitraclip procedure was performed to treat a mixed mitral regurgitation (mr) grade 4+ with enlarged atrium and tethered posterior leaflet.Visualization was noted to be challenging due to anatomy.First clip (ntw) was placed a2/p2.It was indicated that leaflet coaptation and insertion was not satisfactory in all views.A second clip (nt) was advanced to the right atrium.When the second clip was inserted into the left atrium, the first clip was observed to detach from the posterior leaflet (single leaflet device attachment (slda)).No tissue/leaflet damage was observed due to the slda.The nt clip was placed a2/p2 lateral to the first clip.Mr was reduced to grade 1.There was no clinically significant delay in the procedure and no adverse patient sequelae.

• 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: 18580965
• MDR Text Key: 333739832
• Report Number: 2135147-2024-00356
• 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
• Report Date: 01/25/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0705-NTW
• Device Lot Number: 30823R1120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2023
• 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
• Treatment: 1 MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 53 KG