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

Model Number CDS0701-NTW

Device Problem Incomplete Coaptation (2507)

Patient Problems High Blood Pressure/ Hypertension (1908); Nausea (1970); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 06/25/2021

Event Type  Injury  

Manufacturer Narrative

The clip remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report single leaflet device attachment and recurrent mitral regurgitation.On (b)(4) 2021, a mitraclip procedure was performed to treat mixed mitral regurgitation (mr) with a grade of 4.One clip was successfully implanted, reducing mr to a grade of 1.The following day, the patient became violently sick which caused the patients blood pressure to significantly increase.The significant increase in blood pressure caused the clip to detach from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda), causing mr to increase to a grade of 3-4.It is unknown what caused the patient to get sick, but medication was administered.On (b)(6) 2021, a second mitraclip procedure was performed to stabilize the slda and treat the recurrent mr.One clip was successfully implanted, reducing mr to a grade of 1-2.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 available information, the reported single leaflet device attachment (slda) appear to be a cascading event of the reported hypertension.A cause for the reported nausea could not be determined.The reported nausea resulted in hypertension.Lastly, the reported medical intervention, required medication and hospitalization were a result of case specific circumstances.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
• MDR Report Key: 12197227
• MDR Text Key: 262472335
• Report Number: 2024168-2021-06226
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230967
• UDI-Public: 08717648230967
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/02/2021

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: 03/01/2022
• Device Model Number: CDS0701-NTW
• Device Catalogue Number: CDS0701-NTW
• Device Lot Number: 10301R162
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/25/2021
• Initial Date FDA Received: 07/20/2021
• Supplement Dates Manufacturer Received: 08/26/2021
• Supplement Dates FDA Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR