FDA Adverse Event Injury Summary report: N

MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

MDR report key: 10176801 · Received June 19, 2020

Report

Report Number: 2024168-2020-05197
Event Type: Injury
Date Received: June 19, 2020
Date of Event: June 8, 2020
Report Date: June 19, 2020
Manufacturer: ABBOTT VASCULAR
Product Code: DRA
PMA / PMN Number: K161985
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

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 THE REPORTED ISSUE. THE REPORTED PATIENT EFFECT OF ATRIAL SEPTAL DEFECT REQUIRING INTERVENTION AS LISTED IN THE MITRACLIP NT SYSTEM INSTRUCTIONS FOR USE, CE, IS A KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH MITRACLIP PROCEDURES. BASED ON THE AVAILABLE INFORMATION, THE REPORTED ATRIAL PERFORATION WAS DUE TO PROCEDURAL CONDITIONS. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

Description of Event or Problem · 1

THIS IS FILED TO REPORT THE PATENT FORAMEN OVALE (PFO) AFTER USE OF THE STEERABLE GUIDE CATHETER. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH AN MR GRADE OF 4. TWO CLIPS WERE IMPLANTED SUCCESSFULLY REDUCING MR TO 2. AFTER REMOVAL OF THE STEERABLE GUIDE CATHETER, A PATENT FORAMEN OVALE (PFO) WITH RIGHT-LEFT, LEFT-RIGHT SHUNT WAS OBSERVED. A CLOSURE DEVICE WAS IMPLANTED FOR TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
640057	MITRACLIP SYSTEM STEERABLE GUIDE CATHETER	VALVE REPAIR	DRA	ABBOTT VASCULAR		00129U302

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	MITRACLIP DELIVERY SYSTEM X2