FDA Adverse Event Malfunction Summary report: N

ECLIPSE FILTER

MDR report key: 10303368 · Received July 21, 2020

Report

Report Number: 2020394-2020-04758
Event Type: Malfunction
Date Received: July 21, 2020
Report Date: July 21, 2020
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

THE LOT NUMBER FOR 12 OF THE 22 REPORTED MALFUNCTIONS WAS PROVIDED, THEREFORE LOT HISTORY REVIEWS WERE PERFORMED. THE SAMPLES WERE NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION HOWEVER, MEDICAL RECORDS WERE PROVIDE FOR REVIEW FOR ALL THE MALFUNCTIONS AS WELL AS IMAGES WERE PROVIDED FOR TWO MALFUNCTIONS. FOR TWENTY OF THE MALFUNCTIONS, THE INVESTIGATION IS CONFIRMED FOR PERFORATION. FOR THE REMAINING TWO MALFUNCTIONS, THE INVESTIGATION IS CONFIRMED FOR PREFORMATION, BUT IS UNCONFIRMED FOR TILT. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE DEVICES ARE LABELED FOR SINGLE USE. (CORPORATE LOT: GFVF4248, GFUB1685, GFXB3216, GFUF3055, GFUJ2236, GFXA3809, GFUL1906, GFUC2337, UNKNOWN).

Description of Event or Problem · 1

THIS REPORT SUMMARIZES 22 MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL EC500F VENA CAVA FILTER ALLEGEDLY EXPERIENCED PERFORATION. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. OF THE 22 MALFUNCTION, 22 PATIENTS WERE INVOLVED WITH NO PATIENT CONSEQUENCES OR IMPACT. THE PATIENTS' AGES RANGED FROM 35 TO 83 YEARS OF AGE. OF THE REPORTED PATIENTS, 11 WERE MALE AND 11 WERE FEMALE. SIX PATIENTS' WEIGHTS RANGED FROM 210 - 480 POUNDS. THE REMAINING PATIENTS' WEIGHTS WERE NOT PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
766811	ECLIPSE FILTER	VENA CAVA FILTER	DTK	BARD PERIPHERAL VASCULAR, INC.		GFUC2336, GFUB1656, GFWD0778

Patients

Seq	Age	Sex	Outcome	Treatment
1