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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP XTR DELIVERY SYSTEM; MITRACLIP DELIVERY SYSTEM

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AV-TEMECULA-CT MITRACLIP XTR DELIVERY SYSTEM; MITRACLIP DELIVERY SYSTEM Back to Search Results
Catalog Number CDS0601-XTR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Neurological Deficit/Dysfunction (1982); Thrombosis (2100)
Event Date 12/13/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 thrombosis, neurological deficit and medical intervention.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.One clip was implanted, reducing the mr to <1.Post-procedure, the echocardiogram revealed thrombosis in the left atrium.The physician stated the clip contributed to the thrombosis.Heparin was administered to the patient.It was noted that approximately 4 days post-procedure, the patient has not woken up from the anesthesia.A computed tomography (ct) showed thrombosis in the right carotid.The patient was transferred to another facility for treatment.The thrombosis was successfully extracted through percutaneous transluminal intervention (pti).The clip is stable on both leaflets.No additional information was provided.
 
Manufacturer Narrative
Internal file number - (b)(4).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Based on the information reviewed, a definitive cause for the thrombosis could not be determined.In addition, the reported neurological deficit/dysfunction appears to be a result of the thrombus in the right carotid artery.The reported patient effect of mitraclip implant thrombosis as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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Brand Name
MITRACLIP XTR DELIVERY SYSTEM
Type of Device
MITRACLIP DELIVERY SYSTEM
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
MDR Report Key8209361
MDR Text Key131826071
Report Number2024168-2019-00014
Device Sequence Number1
Product Code NKM
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
Remedial Action Other
Type of Report Initial,Followup
Report Date 03/22/2019
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 Date07/23/2019
Device Catalogue NumberCDS0601-XTR
Device Lot Number80723U111
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/13/2018
Initial Date FDA Received01/02/2019
Supplement Dates Manufacturer Received03/18/2019
Supplement Dates FDA Received03/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
STEERABLE GUIDE CATHETER; STEERABLE GUIDE CATHETER
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age89 YR
Patient Weight74
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