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

Catalog Number CDS0702-NTW

Device Problem Incomplete Coaptation (2507)

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

Event Date 02/28/2024

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 challenging patient anatomy.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Na.

Event Description

It was reported that a patient presented with grade 4 functional mitral regurgitation (mr), difficult anatomy with reported cleft in anterior leaflet segment 2 (a2), and a small posterior leaflet at grasping areas (lateral and medial 7mm) for a mitraclip procedure.The first mitraclip ntw was implanted on anterior and posterior leaflet segments 3 (a3-p3) with success targeting the medial jet.During use of the second ntw to target a1-p1, the clip was in the left atrium and did not come in contact with the first clip when the p3 leaflet was detached from the first clip.A single leaflet device attachment (slda) occurred with first clip.There was no leaflet damage or rupture of chordae observed.Per the physician, the leaflet was small and fragile, which contributed to the slda.The second clip was implanted to stabilize the slda and reduce the jet at lateral side of the clip.The first clip remains very stable and attached to the anterior leaflet.The mr was reduced to grade 2.There were no adverse patient sequelae or clinically significant delay.

• 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: 18924693
• MDR Text Key: 337914298
• Report Number: 2135147-2024-01215
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0702-NTW
• Device Lot Number: 30816R1091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2023
• 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: MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention