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

Model Number N/A

Device Problem Unintended Movement (3026)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 09/14/2022

Event Type  Death  

Event Description

This is filed to report the clip opening while locked and patient death.It was reported that on (b)(6) 2022 a patient presented with grade 4 mixed mitral regurgitation (mr).All devices were prepared and used in accordance with the instructions for use (ifu).A mitraclip xtw (11014r329) was deployed.Post-deployment, the clip opened more than 5 degrees but the clip remained stable on the valve.The physician decided to place an additional clip.As the second clip (20421r143) was attempted to be in the straddled position, the patient's blood pressure and blood oxygenation decreased.Intervention was performed, however, was not successful and the patient died.No additional information was provided.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional mitraclip device referenced in b5 is filed under a separate medwatch report number.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).

Manufacturer Narrative

All available information was investigated, and the reported unintended movement associated with clip open while locked could not be replicated in the returned condition via returned device analysis.The reported unintended movement associated with clip opened while locked appears to be related to an open trend exception.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 did not indicate a lot-specific quality issue.Death and hypotension are listed in the instructions for use as a known possible complication associated with mitraclip procedures.A cause for the reported hypotension could not be determined.The reported death appears to be related to the reported hypotension.There is no indication of a product issue with respect to manufacture, design, or labeling.This event was further reviewed by a clinical staff engineer r&d, and the reviewer stated that, ¿one (1) fluoroscopic video of the reported device was provided.In the video, a single, fully deployed clip and distal tip of the sgc can be visualized; there is no cds in view.This indicates the video was taken post deployment of the reported clip.The clip is angulated relative to the fluoro view, such that the clip arm plane is visualized at an angle.Based on the video, the clip arm angle appears to be ~30° - 40°; this is an estimation based on visual assessment with the naked eye and cannot be confirmed.The clip appears to be stable, with no further clip arm opening evident in the video.No pre-deployment cine of the reported clip was provided; as such, no assessment or comment regarding the pre-deployment state of the clip (clip arm angle prior to dc detachment), when and/or by how much the clip opened, can be made.There are no additional observations based on the video.¿ in addition, the complaint was reviewed by global medical affairs director transcatheter mitral and tricuspid interventions for medical review.The reviewer stated, ¿in this case of grade 4 mixed mitral regurgitation, a first clip was successfully deployed.Post deployment, the clip opened more than 5 degrees but remained stable on the valve.It was decided to place an additional clip but as it was attempted to be in the straddled position, the patient's blood pressure and blood oxygenation decreased and the patient ultimately died.According to the physician, the deterioration of the clinical condition was not related to the device.There is no evidence that death was related to the device but it was likely related to the procedure.¿ 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: 15569011
• MDR Text Key: 301465722
• Report Number: 2135147-2022-01539
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 01/10/2023

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: 10/20/2022
• Device Model Number: N/A
• Device Catalogue Number: CDS0702-XTW
• Device Lot Number: 11014R329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2022
• Initial Date FDA Received: 10/10/2022
• Supplement Dates Manufacturer Received: 01/04/2023
• Supplement Dates FDA Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2021
• 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
• Patient Outcome(s): Death