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

Catalog Number CDS0706-NT

Device Problem Incomplete Coaptation (2507)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 08/23/2023

Event Type  malfunction  

Event Description

This is filed to report a single leaflet device attachment (slda), and hypertension.It was reported that a mitraclip procedure was performed to treat a functional mitral regurgitation (mr) with grade of 4.The patient presented with restricted anterior and posterior leaflets, and robust chordae.The first clip was implanted with no reported issue.The second clip was deployed lateral a2/p2, reducing mr to grade 2.After the steerable guide catheter (sgc) was removed and the patient was waking up, it was noted that blood pressure increased to about 140mmhg.It was noted that the clip had come out of the anterior leaflet (single leaflet device attachment (slda)).Mr increased to moderate.The physician was comfortable with the result.Because the procedure was completed, a third clip was not used.Anesthesia treated hypertension, which was caused due to the patient waking from general anesthesia.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 lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no similar complaints from the lot.All available information was investigated, and a cause for the reported slda per the account could not be determined.Hypertension per the account was related to general anesthesia.Hypertension is a known possible complication associated with mitraclip procedures.Serious injury/illness/impairment was 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 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: 17745407
• MDR Text Key: 323400219
• Report Number: 2135147-2023-03980
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037367
• UDI-Public: 05415067037367
• 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
• Report Date: 09/14/2023

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: 09/19/2023
• Device Catalogue Number: CDS0706-NT
• Device Lot Number: 20919R2043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• 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
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Male