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

Model Number CDS0701-XT

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Difficult to Open or Close (2921)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 09/23/2021

Event Type  Injury  

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.

Event Description

This is filed to report difficult to remove, tissue damage it was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.It was noted bilateral posterior prolapse.The first clip was implanted on the medial side.A second clip delivery system (cds) was to be advanced to the mitral valve and placed on the lateral side; however, the clip would not fully close.Reportedly, visualizing the clip during steering was difficult due to a severely enlarged left atrium.Due to tension, the clip could not cross into the valve.The clip was inverted to be removed from the valve, but the clip became stuck.Imaging showed tissue wrapped around the clip arms.The physician under straddled the cds to free the clip.The clip arms were able to close and the cds was removed from the patient.Additional treatment was not performed.One clip was implanted, reducing mr to 2-3.There was no clinically significant delay in the procedure.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 lots that would have contributed to this event and a review of the complaint history identified no similar incident reported from this lot.Based on the information reviewed and without a device to analyze, a cause for the reported clip close difficulty could not be determined.The reported poor imaging was due to challenging patient anatomy.The reported failure to advance and difficult to remove from anatomy appear to be a result of procedural circumstances.Tissue damage was a cascading event of reported difficult to remove from anatomy.Additionally, the patient effect of tissue damage is listed in the mitraclip g4 system instructions for use as a known possible complication associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.

Event Description

N/a.

• 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: 12623671
• MDR Text Key: 276134807
• Report Number: 2024168-2021-09172
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230981
• UDI-Public: 08717648230981
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2021

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: 11/08/2021
• Device Model Number: CDS0701-XT
• Device Catalogue Number: CDS0701-XT
• Device Lot Number: 01107U134
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2021
• Initial Date FDA Received: 10/13/2021
• Supplement Dates Manufacturer Received: 10/20/2021
• Supplement Dates FDA Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2020
• 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; 1 IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 73 KG