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

Catalog Number CDS0705-XT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tricuspid Valve Stenosis (2113); Unspecified Tissue Injury (4559)

Event Date 12/14/2021

Event Type  Injury  

Event Description

This is being filed to report the clip caused the chords to rupture requiring open heart surgery.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with grade 4.The first clip delivery system (cds) (cds0705-xtw, 10920r121) was advanced to the mitral valve and the xtw clip was implanted.A second cds (cds0705-xt, 10510r121) was advanced, and an attempt was made to place the second xt clip medial to the first clip, but mr did not decrease, and the mean pressure gradient increased to 8 mmhg.The clip was repositioned many times, but a good result could not be achieved, it was thought because the first clip had movement and twisted the valve, but remained stable on both leaflets.However, when trying to position the clip in the left ventricle, a chordal rupture occurred, and mr increased.The xt clip was not implanted and the pressure gradient returned to baseline of 2mmhg.A third cds (cds0705-nt, 10324r205) was advanced, and the nt clip was implanted laterally to treat the tissue damage created, but mr remained at 4.The patient had mitral valve replacement on (b)(6) 2021 and is doing well.No additional information was provided.

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional mitraclip device is filed under a separate medwatch report number.

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional mitraclip device is filed under a separate medwatch report number.

Event Description

This is being filed to report the clip caused the chords to rupture requiring open heart surgery.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with grade 4.The first clip delivery system (cds) (cds0705-xtw, 10920r121) was advanced to the mitral valve and the xtw clip was implanted.A second cds (cds0705-xt, 10510r121) was advanced, and an attempt was made to place the second xt clip medial to the first clip, but mr did not decrease, and the mean pressure gradient increased to 8 mmhg.The clip was repositioned many times, but a good result could not be achieved, it was thought because the first clip had movement and twisted the valve, but remained stable on both leaflets.However, when trying to position the clip in the left ventricle, a chordal rupture occurred, and mr increased.The xt clip was not implanted and the pressure gradient returned to baseline of 2mmhg.A third cds (cds0705-nt, 10324r205) was advanced, and the nt clip was implanted laterally to treat the tissue damage created, but mr remained at 4.The patient had mitral valve replacement on (b)(6) 2021 and is doing well.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Based on the information reviewed, the cause for the reported tricuspid stenosis cannot be determined.The reported patient effect of tissue injury appears to be related to procedural circumstance/user technique.The reported patient effect of unspecified tissue injury and tricuspid stenosis are listed in the instructions for use as a known possible complication associated with mitraclip procedures.The unexpected medical intervention, hospitalization, and surgical intervention were a result of case-specific circumstance.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13179027
• MDR Text Key: 286236081
• Report Number: 2024168-2022-00191
• 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,Followup
• Report Date: 01/27/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2022
• Device Catalogue Number: CDS0705-XT
• Device Lot Number: 10510R121
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2021
• Initial Date FDA Received: 01/06/2022
• Supplement Dates Manufacturer Received: 01/14/2022
• Supplement Dates FDA Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2021
• 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; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention; Hospitalization; Disability
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 59 KG