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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT; MITRACLIP DELIVERY SYSTEM Back to Search Results
Catalog Number CDS0502
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem Tissue Damage (2104)
Event Date 03/06/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
 
Event Description
This is filed to report the suspected leaflet damage.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.The clip delivery system (cds) was advanced to the mitral valve; however, it was not possible to grasp both leaflets, and some chordal damage occurred.There were difficulties visualizing the clip during the procedure due to very bad image quality.The cds was removed and the procedure was discontinued.The mr remained at 4.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
 
Manufacturer Narrative
(b)(4).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 this event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated and the reported failure to adhere or bond (difficulty grasping the leaflets and leaflet capture) was related to the challenging patient anatomy specifically the large atrium, very high fossa ovalis and procedural circumstances like difficulties visualizing the clip.The reported poor image resolution was related to the visualization limitation due to very bad image quality.The reported tissue damage appears and to be related to procedural circumstances (maneuvers related to grasping attempts since the patient had a very challenging anatomy).The reported patient effect of mitral valve injury 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 design, manufacturing, or labeling of the device.
 
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Brand Name
MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT
Type of Device
MITRACLIP DELIVERY SYSTEM
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
MENLO PARK, CA REG# 3005070406
abbott vascular
26531 ynez rd.
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key7393046
MDR Text Key104198286
Report Number2024168-2018-02441
Device Sequence Number1
Product Code NKM
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P100009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 06/05/2018
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 Date12/28/2018
Device Catalogue NumberCDS0502
Device Lot Number71228U152
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/06/2018
Initial Date FDA Received04/03/2018
Supplement Dates Manufacturer Received06/01/2018
Supplement Dates FDA Received06/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
STEERABLE GUIDE CATHETER
Patient Outcome(s) Other;
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