FDA Adverse Event Malfunction Summary report: Y

ECLIPSE FILTER SYSTEM - FEMORAL

MDR report key: 12200118 · Received July 20, 2021

Report

Report Number: 2020394-2021-80648
Event Type: Malfunction
Date Received: July 20, 2021
Report Date: July 20, 2021
Manufacturer: BARD PERIPHERAL VASCULAR, INC.
Product Code: DTK
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AZ, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

OF THE REPORTED FIVE MALFUNCTIONS, LOT NUMBER WERE PROVIDED FOR THREE MALFUNCTIONS AND THE LOT HISTORY REVIEW WERE PERFORMED. THE SAMPLES WERE NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. HOWEVER; MEDICAL RECORDS WERE RECEIVED FOR ALL FIVE MALFUNCTIONS AND ADDITIONALLY IMAGE WAS PROVIDED FOR ONE MALFUNCTION. THEREFORE, FOR ONE MALFUNCTION THE INVESTIGATION IS CONFIRMED FOR THE REPORTED FILTER TILT AND PERFORATION AND FOR THE REMAINING FOUR MALFUNCTIONS THE INVESTIGATION IS CONFIRMED FOR THE REPORTED PERFORATION AND INCONCLUSIVE FOR THE FILTER TILT. BASED ON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE DEVICES ARE LABELED FOR SINGLE USE. (CORPORATE LOT NO: UNKNOWN).

Description of Event or Problem · 1

A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL EC500F VENA CAVA FILTER ALLEGEDLY EXPERIENCED FILTER TILT AND PERFORATION. THESE INFORMATION'S WERE RECEIVED FROM A VARIOUS SOURCES. ALL FIVE MALFUNCTIONS INVOLVED PATIENT WITH NO PATIENT CONSEQUENCES. OF THE FIVE PATIENTS, TWO WERE FEMALE AND THREE WERE MALE, FOUR PATIENTS AGE RANGED BETWEEN 53-77 YEARS AND THREE PATIENT WEIGHS IN THE RANGE BETWEEN 150 - 295 LBS. ALL OTHER PATIENT DETAILS WERE NOT PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1094256	ECLIPSE FILTER SYSTEM - FEMORAL	VENA CAVA FILTER	DTK	BARD PERIPHERAL VASCULAR, INC.		GFVA2435, GFYC1112, GFUA4104

Patients

Seq	Age	Sex	Outcome	Treatment
1