FDA.reportPublic FDA data

MAUDE MDR 9823793

MDR report key
9823793
Report number
2024168-2020-02314
Event key
0
Event type
3
Date of event
2020-01-29
Date received
2020-03-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. LINDSEY BELL
Address
26531 YNEZ RD. TEMECULA CA 92591 US
Phone
951-951-9519
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1STEERABLE GUIDE CATHETERVALVE REPAIRABBOTT VASCULARDRASGC030281114U124N R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-120

Event Narratives#

N

Patient 1

(B)(4). THE DEVICE WAS RECEIVED. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

D

Patient 1

REVISED. IT WAS REPORTED THAT THE MITRACLIP PROCEDURE WAS PERFORMED TO TREAT MIXED MITRAL REGURGITATION WITH GRADE OF 4. THE PATIENT HAD A SMALL ANATOMY WITH SMALL ATRIUM, THE SEPTAL PUNCTURE WAS A HUGE PROBLEM AND THE HEIGHT OVER THE VALVE WAS 3.3 CM. THE STEERABLE GUIDE CATHETER (SGC) WAS INSERTED AND ADVANCED INTO ARTERY, PER THE INSTRUCTION FOR USE (IFU). THE PHYSICIAN HAD TO MANIPULATE THE CLIP DELIVERY SYSTEM (CDS) TO GAIN HEIGHT TO THE MITRAL VALVE; THEREFORE, MORE CURVES WERE APPLIED TO THE CDS THAN USUAL AND TENSION WAS VERY HIGH. BEFORE CLIP DEPLOYMENT, THE GRIPPER LINE BROKE AS DUE TO TOO MUCH TENSION. THE PROCEDURE WAS ABORTED AS THE SECOND CDS WOULD HAVE THE SAME ISSUE. THE CDS WITH THE CLIP ATTACHED AND GRIPPER LINE WERE REMOVED. THERE WERE NO CLIPS IMPLANTED, MR REMAINED AT 4. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE CDS WAS RETURNED INSIDE THE SGC AND ANALYSIS REVEALED THAT THE SGC SOFT TIP WAS TORN. NO ADDITIONAL INFORMATION WAS PROVIDED.