FDA.reportPublic FDA data

MAUDE MDR 9819933

MDR report key
9819933
Report number
2024168-2020-02285
Event key
0
Event type
3
Date of event
2020-02-24
Date received
2020-03-11
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 VASCULARDRASGC030291207U233R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-1101. O

Event Narratives#

N

Patient 1

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT. BASED ON THE INFORMATION REVIEWED, A CONCLUSIVE CAUSE FOR THE REPORTED PERICARDIAL EFFUSION CANNOT BE DETERMINED. THE REPORTED PATIENT EFFECT OF PERICARDIAL EFFUSION AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE (IFU), IS A KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH MITRACLIP PROCEDURES. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

D

Patient 1

THIS IS BEING FILED TO REPORT THE PERICARDIAL EFFUSION. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT MIXED MITRAL REGURGITATION (MR) WITH A GRADE OF 4. ONE CLIP WAS IMPLANTED, REDUCING MR TO 1-2. AFTER THE PROCEDURE, A PERICARDIAL EFFUSION WAS NOTED AT THE RIGHT APEX. THE PATIENT WAS MONITORED FOR 10 MINUTES AND THE EFFUSION NEARLY DISAPPEARED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.