MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP NTR CLIP DELIVERY SYSTEM; VALVE REPAIR

Model Number CDS0601-NTR

Device Problem Incomplete Coaptation (2507)

Patient Problem Failure of Implant (1924)

Event Date 10/24/2022

Event Type  Death  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional mitraclip device referenced is filed under separate medwatch report number.

Event Description

This is filed to report single leaflet device attachment and death.It was reported that on (b)(6) 2022, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) grade 4+ with prolapsed posterior leaflet, flail and a pre-existing ruptured chord.Two mitraclips (20303r121 and 20321r151) were implanted.However, during the procedure, it was noted that there was a lot of tension on the steerable guide catheter (sgc) due to the axial rotation as the clamp and sgc bend amplitude were high.After the two clips were released the tension on the sgc was large and it was suspected that there was +/- knob rebound.The procedure was complete with the mr reduced to a grade of 2+.The next morning on (b)(6) 2022, the patient died.The cause of death was due to single leaflet device attachment (slda).Both implanted clips were detached from the posterior leaflet.The slda blocked the left ventricular outflow tract which caused the left ventricular dysfunction.It was suspected that the sgc axial problem during the procedure exerted great tension on the leaflet of mitral valve and affected the clamping stability of the two clips.No additional information was provided.

Manufacturer Narrative

All available information was investigated, and the reported incomplete coaptation (single leaflet device attachment (slda)) could not be replicated in a testing environment due to the returned condition of the device (clip was not returned).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 incidents reported from this lot.Based on the information reviewed, the reported incomplete coaptation (single leaflet device attachment (slda)) appears to due patient anatomy (prolapsed posterior leaflet, flail and a pre-existing ruptured chord) and procedural conditions.In addition, death is listed in the instructions for use as a known possible complication associated with mitraclip procedures.A cause for the reported death could not be determined.There is no indication of a product issue with respect to manufacture, design or labeling.The additional mitraclip device referenced in b5 is filed under separate medwatch report number.

Event Description

N/a.

• Brand Name: MITRACLIP NTR CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• 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: 15798770
• MDR Text Key: 303668463
• Report Number: 2135147-2022-02064
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 12/28/2022

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: 03/21/2023
• Device Model Number: CDS0601-NTR
• Device Catalogue Number: CDS0601-NTR
• Device Lot Number: 20321R151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2022
• Initial Date FDA Received: 11/15/2022
• Supplement Dates Manufacturer Received: 12/07/2022
• Supplement Dates FDA Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2022
• 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: 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Death