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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); Improper or Incorrect Procedure or Method (2017); Incomplete Coaptation (2507); Device Damaged by Another Device (2915)
Patient Problems Low Blood Pressure/ Hypotension (1914); Tissue Damage (2104)
Event Date 03/06/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).Medical devices: steerable guide catheter, 1 implanted mitraclip, 1 clip delivery system.Although the 3rd mitraclip clip arms were not confirmed to be perpendicular to the line of coaptation; this clip was eventually implanted lateral to the 2nd slda mitraclip.Post procedure, the mr was grade 4+, worse than pre-procedure mr.The first implanted mitraclip remained stable and well seated.The procedure ended and the patient was discharged to hospice.There was no additional information provided regarding this issue.Reported device code -failure to follow steps/instructions.The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional, relevant information.The two other mitraclips are filed in separated medwatch reports.
 
Event Description
This report is filed on the second clip delivery system (cds 71103u165).The clip detached from one leaflet and remains attached to the other leaflet.Tissue damage and hypotension occurred.It was reported that this was a mitraclip procedure treating degenerative mitral regurgitation (mr) grade 4 with anterior 2 leaflet flail.One mitraclip (71027u288) was implanted without issue.A 2nd clip delivery system (cds 71103u165) was advanced to the mitral valve.During advancement, this cds interacted with the first implanted mitraclip.The second cds had a poor grasp on the leaflets and, against advice, clip deployment was initiated.While flossing the gripper line without resistance, clip movement was noted on the leaflet.Once deployed, the posterior leaflet came out of the clip (single leaflet device attachment-slda).The mr increased and tissue damage was suspected.Blood pressure dropped and medications were provided.As treatment for the slda, a third clip delivery system (cds 71103u166) was advanced to the mitral valve.During positioning, the 3rd cds interacted with subvalvular tissue.The 3rd cds could be retracted into the left atrium, pulling the mitral valve upward.This 3rd cds caught the 2nd implanted mitraclip, pushing the 2nd implanted mitraclip on top of the 1st implanted mitraclip resulting in severe tissue damage and no leaflet coaptation.The 1st and 2nd implanted mitraclips were now formed as an upside-down t, both stacked on each other.More tissue damage was suspected with even worsening mr.
 
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.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.Based on the information provided, the reported partial clip movement (failure to adhere or bond) and slda appear to be primarily due to the user error of clip deployment despite an unsatisfactory leaflet insertion.Additionally, patient morphology/pathology of a leaflet flail may also have contributed to the reported partial clip movement and slda.Device damaged by another (damaged) appears to be due to a combination of patient morphology/pathology and user technique/procedural circumstances.The reported tissue damage appears to be a result of procedural circumstances and due to device damaged by another and slda.The reported hypotension was likely a cascading effect of tissue damage.The reported patient effects of mitral valve injury (tissue damage) and hypotension, as listed in the mitraclip system instructions for use (ifu), are known possible complications associated with mitraclip procedures.It should be noted that in the mitraclip ifu instructs the user to use echocardiographic imaging to verify valve function, satisfactory coaptation, and insertion of both leaflets by observation of leaflet immobilization, single or multiple valve orifice(s), limited leaflet mobility relative to the tips of both clip arms, and adequate mr reduction.As it was reported that the leaflet insertion was not satisfactory prior to deployment, this likely resulted in the partial clip movement and single leaflet device attachment (slda).Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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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 Key7379943
MDR Text Key103776628
Report Number2024168-2018-02264
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 06/15/2018
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 Date11/04/2018
Device Catalogue NumberCDS0501
Device Lot Number71103U165
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/06/2018
Initial Date FDA Received03/28/2018
Supplement Dates Manufacturer Received06/04/2018
Supplement Dates FDA Received06/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age91 YR
Patient Weight52
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