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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR MITRACLIP DELIVERY SYSTEM; VALVE REPAIR Back to Search Results
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.
 
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Brand Name
MITRACLIP DELIVERY SYSTEM
Type of Device
VALVE REPAIR
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
MDR Report Key10532599
MDR Text Key206956633
Report Number2024168-2020-07688
Device Sequence Number1
Product Code NKM
UDI-Device Identifier08717648226342
UDI-Public08717648226342
Combination Product (y/n)N
PMA/PMN Number
P100009
Number of Events Reported1
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 Date12/11/2020
Device Model NumberCDS0601-NTR
Device Catalogue NumberCDS0601-NTR
Device Lot Number91212U247
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/26/2020
Initial Date FDA Received09/14/2020
Supplement Dates Manufacturer Received10/16/2020
Supplement Dates FDA Received11/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
OTHER MITRACLIP
Patient Outcome(s) Hospitalization;
Patient Age69 YR
Patient Weight78
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