• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Problems Mitral Valve Stenosis (1965); Tissue Damage (2104)
Event Date 02/28/2018
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 clip delivery system 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 tissue damage and mitral stenosis.It was reported that the patient, with grade 4 mixed mitral regurgitation (mr) and a mean pressure gradient of 2mmhg, underwent a mitraclip procedure.Two clips were successfully implanted one at the anterior 2/posterior 2 (a2/p2) leaflet segment and the other at the anterior 3/posterior 3 (a3/p3) leaflet segment.The mean pressure gradient increased to 3 mmhg, but mr was reduced to grade 2-3.It was decided to implant a third clip between the two previously implanted clips.Some difficulty was noted grasping the leaflets and a new jet was noted between the two implanted clips.It was felt that the new jet was due to a leaflet perforation.The clip was not implanted and the clip delivery system was removed without issue.An amplatzer plug was placed to seal the leaflet perforation.The procedure ended with mr at grade 1.The mean pressure gradient increased to 7 mmhg.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.Additionally, a review of the complaint history identified no similar incidents reported from this lot.The reported patient effects of mitral stenosis and mitral valve injury (tissue damage) as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.All available information was investigated and a definitive cause for the reported failure to adhere or bond could not be determined.The reported mitral valve injury (tissue damage) appears to be related to the reported failure to adhere or bond and patient effect of mitral stenosis was due to procedural circumstances as the mean gradient pressure remained 7mmhg at the end of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing or labeling of the device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7363588
MDR Text Key103246343
Report Number2024168-2018-02084
Device Sequence Number1
Product Code NKM
Combination Product (y/n)N
Reporter Country CodeSZ
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 05/23/2018
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 Date10/25/2018
Device Catalogue NumberCDS0502
Device Lot Number71025U162
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/28/2018
Initial Date FDA Received03/22/2018
Supplement Dates Manufacturer Received05/18/2018
Supplement Dates FDA Received05/23/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2017
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 CATHETERIMPLANTED MITRACLIP (X2)
Patient Outcome(s) Required Intervention;
-
-