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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 CDS0501
Device Problems Failure To Adhere Or Bond (1031); Incomplete Coaptation (2507)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/02/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
 
Event Description
This is filed to report the single leaflet device attachment (slda).It was reported this was a mitraclip procedure performed to treat mixed mitral regurgitation (mr) with a grade of 4+.The transseptal puncture was difficult due to atrial dilatation; the puncture was low with an aorta hugger.Imaging was challenging due to the anatomy.Standard steering techniques were used to gain height to the mitral valve.The clip delivery system (cds) (70925u343) was advanced to the mitral valve, grasping was difficult due to the annular dilation and due to bi-leaflet prolapse.The leaflets were eventually grasped, and the clip was deployed.However, two minutes later, when removing "m" from the device to remove the delivery system; it was noted that the clip detached from the posterior leaflet and remained attached to the anterior leaflet (slda).The mr was 3+.Since it took approximately 2 hours and 20 minutes to grasp with the clip, the decision was made to discontinue the procedure.The patient remained hospitalized for a second mitraclip procedure, which was performed on (b)(6) 2018.During the second procedure, leaflet grasping was unsuccessful with the cds due to the anatomy.The cds was removed with the clip and the procedure was aborted.The mr remains 3+.The patient is stable.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 the event.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.All available information was investigated and the single leaflet device attachment (slda) and failure to adhere/bond (difficult grasping) and poor image resolution in this incident appears to be related to patient morphology/challenging anatomy (bi-leaflet prolapse with annular dilation, coaptation length 0mm, dilated right and left atrium with rotation of the heart).Based on the information reviewed, 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 Key7373477
MDR Text Key103559489
Report Number2024168-2018-02202
Device Sequence Number1
Product Code NKM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
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 Date09/26/2018
Device Catalogue NumberCDS0501
Device Lot Number70925U343
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/02/2018
Initial Date FDA Received03/27/2018
Supplement Dates Manufacturer Received05/31/2018
Supplement Dates FDA Received06/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2017
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) Hospitalization; Required Intervention;
Patient Age92 YR
Patient Weight95
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