• 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 XTR DELIVERY SYSTEM; 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 XTR DELIVERY SYSTEM; MITRACLIP DELIVERY SYSTEM Back to Search Results
Catalog Number CDS0601-XTR
Device Problem Incomplete Coaptation (2507)
Patient Problems High Blood Pressure/ Hypertension (1908); Neurological Deficit/Dysfunction (1982); Tissue Damage (2104)
Event Date 04/03/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 other incidents from this lot.The reported patient effect of mitral valve injury (tissue damage) as listed in the mitraclip system instructions for use is a known possible complication associated with mitraclip procedures.All available information was investigated and a definitive cause for the reported single leaflet device attachment (slda) and tissue damage could not be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
 
Event Description
This is filed for single leaflet device attachment (slda) and tissue damage.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4+.One clip was implanted without issue and mr was reduced to grade 2+.Final echocardiogram was performed and noted a large mr jet.It could not be confirmed if it was due to an slda at the posterior leaflet or a posterior leaflet tear.Mr increased to grade 4+.One additional clip was implanted, medial to the first, to stabilize the detached clip and mr was reduced to grade 3.Post procedure, the patient was in stable condition.No additional information was provided.
 
Manufacturer Narrative
(b)(4).The reported patient effect of hypertension as listed in the mitraclip ntr/xtr system instructions for use is a known possible complication associated with mitraclip procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.
 
Event Description
Subsequent to the initial 30-day medwatch report, additional information was received, indicating that during the index procedure, after the clip was implanted and before the patient was extubated, the patient became agitated and an increase in blood pressure was noted.The single leaflet device attachment was noted.A second clip was implanted and the mr was reduced to grade 3+.No additional information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
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 Key8553003
MDR Text Key143228785
Report Number2024168-2019-03311
Device Sequence Number1
Product Code NKM
UDI-Device Identifier08717648226366
UDI-Public08717648226366
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 Physician
Remedial Action Other
Type of Report Initial,Followup
Report Date 08/15/2019
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? Yes
Device Operator Health Professional
Device Expiration Date02/21/2020
Device Catalogue NumberCDS0601-XTR
Device Lot Number90221U122
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/03/2019
Initial Date FDA Received04/25/2019
Supplement Dates Manufacturer Received08/12/2019
Supplement Dates FDA Received08/15/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2019
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 Age52 YR
Patient Weight76
-
-