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

Model Number CDS0701-XTW

Device Problems Improper or Incorrect Procedure or Method (2017); Incomplete Coaptation (2507); Difficult to Advance (2920); Unintended Movement (3026)

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

Event Date 08/01/2022

Event Type  Injury  

Manufacturer Narrative

The clip remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.(b)(4).The steerable guide catheter (sgc) reported in is filed under a separate medwatch report number.

Event Description

This is being filed for the second xtw mitraclip that opened while locked, resulting in a single leaflet device attachment.It was reported that on (b)(6) 2022, the patient presented with degenerative mitral regurgitation (mr) grade 4, with a large left atrium, and a2 flail.Reportedly, the transseptal height was high, at 5.9 cm.Although the transseptal height was high and it was difficult to advance due to anatomy, the first mitraclip was successfully implanted.Another xtw mitraclip was attempted to be placed lateral to the first, however, the operator could not lose the excess height, created with the transseptal.Troubleshooting was performed; however, the xtw clip delivery system (cds) was unable to advance.It was determined that a new transseptal puncture was needed.The xtw cds and steerable guide catheter were removed without issue reported.During preparation of the same sgc, a loss of fluid column occurred.The sgc¿s fluid column would not hold.Another transseptal access was performed and a new sgc was used in replacement.The same xtw that had failed to advance earlier was re-advanced and was implanted lateral to the first mitraclip.After deployment, the clip opened while locked and a single leaflet device attachment (slda) had then occurred.The clip detached from the anterior leaflet, while remaining attached to the posterior.As treatment for the slda, a third xtw mitraclip was implanted without an issue reported, stabilizing the slda.The mr was reduced to grade 1-2.There was no adverse patient sequela.No additional information was provided regarding this issue.

Event Description

N/a.

Manufacturer Narrative

The device is included in the field safety notice issued by abbott on (b)(6).2022 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).

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 difficult to advance appears to be related to procedural conditions.A cause for the reported clip open while locked cannot be determined.The slda appears to be a cascading effect of the clip open while lock.The reported user error (improper or incorrect procedure or method) was due to the user re-advancing the cds.The 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.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).

• 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: 15279674
• MDR Text Key: 298454991
• Report Number: 2135147-2022-00875
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2022

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: 02/27/2023
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 20224R427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2022
• Initial Date FDA Received: 08/23/2022
• Supplement Dates Manufacturer Received: 08/22/2022; 10/10/2022
• Supplement Dates FDA Received: 09/08/2022; 10/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2022
• 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: MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 80 KG