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

Catalog Number CDS0705-NT

Device Problem Incomplete Coaptation (2507)

Patient Problem Pain (1994)

Event Date 02/15/2023

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 other complaints reported from this lot.The investigation determined the reported single leaflet device attachment (slda) and poor image resolution appear to be related to patient morphology/pathology.The reported unrelated death was due to procedure/user technique.A cause for the reported pain cannot be determined.Death and pain are listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported unexpected medical intervention was a result of case-specific circumstance there is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

This is filed to report single leaflet device attachment.It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4, a posterior leaflet tethering, and an enlarged atrium.It was noted the mean pressure gradient was 2mmhg and imaging was challenging.One clip was successfully implanted.To further reduce mr, an nt clip (21110r1081) was implanted.However, after deployment, the clip detached from the anterior leaflet and remained attached to the posterior leaflet (single leaflet device attachment/slda), causing mr to return to a grade of 4.An additional nt clip (20526r184) was inserted to stabilize the slda.Grasping was noted to be difficult, but after deployment, mr remained at a grade of 4.It was noted the mean pressure gradient increased to a grade of 6mmhg.Therefore, the procedure was discontinued.Roughly seven hours after the procedure, the patient experienced stomach pain and was sedated.It was noted the patient was wrongly sedated and the sedation is what caused the patient to pass away.The two implanted clips did not cause or contribute to the patient death.No additional information was provided.

• 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: 16502649
• MDR Text Key: 310882251
• Report Number: 2135147-2023-01054
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 03/08/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2023
• Device Catalogue Number: CDS0705-NT
• Device Lot Number: 21110R1081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2023
• Initial Date FDA Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2022
• 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
• Treatment: IMPLANTED MITRACLIP.; STEERABLE GUIDE CATHETER.
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 65 KG