MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP DELIVERY SYSTEM; VALVE REPAIR

Model Number CDS0601-NTR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 08/26/2020

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.

Event Description

This is filed to report prolonged hospitalization and neurological symptoms.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4+.On (b)(6) 2020, 2 clips (00311u165, 91212u247) were implanted, reducing mr to 1+.The next day, the patient experienced neurological symptoms of a stroke.Additional treatment was not performed due to the symptoms were resolved within 24 hours on its own.The patient remained hospitalized for another week to conduct further testing and monitoring.Two ct scans were performed and the test results were inconclusive for a stroke.The physicians stated that the neurological symptoms were possibly due to anesthesia or the mitraclip procedure.The patient recovered fine.The two clips remained stable on both leaflets and mr is 1+.No additional information was provided.

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.Based on the information reviewed, a definitive cause for the reported neurological deficit / dysfunction could not be determined.The hospitalization (required) or prolonged 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 DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10532599
• MDR Text Key: 206956633
• Report Number: 2024168-2020-07688
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648226342
• UDI-Public: 08717648226342
• 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: 11/02/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2020
• Device Model Number: CDS0601-NTR
• Device Catalogue Number: CDS0601-NTR
• Device Lot Number: 91212U247
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 09/14/2020
• Supplement Dates Manufacturer Received: 10/16/2020
• Supplement Dates FDA Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OTHER MITRACLIP
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR
• Patient Weight: 78