MAUDE Adverse Event Report: ABBOTT MEDICAL TRICLIP G4 DELIVERY SYSTEM (TCDS)

Catalog Number TCDS0302-XTW

Device Problems Difficult or Delayed Positioning (1157); Unintended Movement (3026)

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

Event Date 09/23/2021

Event Type  Injury  

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 resulted in this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.All available information was investigated, and a conclusive cause for the reported unintended movement could not be determined in this complaint.The reported difficult or delayed positioning appears to be due poor image resolution.The reported poor image resolution was an outcome of procedural circumstance/operational context.The reported unexpected medical intervention appears to be due to case specific circumstance as one additional clip was placed beneath the first triclip to stabilize it.The device is included in the correction notice issued by abbott on 06 sep 2022 for clips not being able to establish final arm angle (efaa) and/or clip opening while locked (cowl) with the mitraclip and triclip delivery system(s).The two additional clip delivery system (cds) devices referenced are filed under separate medwatch report numbers.

Event Description

It was reported that this was a triclip procedure to treat grade 5 tricuspid regurgitation (tr).Visualization was challenging due to poor imaging.The first triclip (10624r1038) was advanced to the tricuspid valve, grasping was difficult, but the leaflets were eventually grasped.After fully closing the triclip in the anterior-septal commissure it was slightly more open than normal, however there was enough leaflet material to release the triclip.After deploying the triclip, the triclip opened a little more to approximately 40 degrees.A second triclip (10715r2005) was placed beneath the first triclip, stabilizing it.When trying to place a third triclip (10715r2006), it was observed that the second triclip was detached from the anterior leaflet but remained attached to the septal leaflet (single leaflet device attachment/slda).Tr returned to 5 and tissue damage was observed.Grasping was unsuccessful with the third triclip, therefore the triclip was not implanted and was removed.No additional information was provided.As of aug 22, 2022 the device is included in the correction notice due to an increased rate of reports for clips not being able to establish final arm angle (efaa) and clip opening while locked (cowl) with the mitraclip and triclip delivery system(s).

• Brand Name: TRICLIP G4 DELIVERY SYSTEM (TCDS)
• Type of Device: TRICLIP
• 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: 15397617
• MDR Text Key: 299668354
• Report Number: 2135147-2022-01110
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NOT APPROVED
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 09/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2022
• Device Catalogue Number: TCDS0302-XTW
• Device Lot Number: 10624R1038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2024168-9/6/2022-003-C
• Patient Sequence Number: 1
• Treatment: TRICLIP STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention