FDA Adverse Event Death Summary report: N

OPTION RETRIEVABLE VENA CAVA FILTER

MDR report key: 2621329 · Received June 8, 2012

Report

Report Number: 3003862657-2012-00003
Event Type: Death
Date Received: June 8, 2012
Date of Event: May 8, 2012
Report Date: June 8, 2012
Manufacturer: REX MEDICAL, L.P.
Product Code: DTK
PMA / PMN Number: K081410
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

COMPLAINT FOLLOW UP: MULTIPLE ATTEMPTS BY REX MEDICAL PERSONNEL, AS WELL AS (B)(4) (DISTRIBUTOR) PERSONNEL, TO CONTACT THE PHYSICIAN WHO INITIALLY PLACED THE OPTION FILTER AND OBTAIN CASE INFORMATION, IMAGES, VIDEO, ETC. WERE UNSUCCESSFUL. COMPLAINT SAMPLE EVALUATION: THE COMPLAINT SAMPLE WAS NOT RETURNED TO REX FOR EXAMINATION BY THE ENGINEERING TEAM. RETAIN DEVICE EVALUATION: THERE WERE NO RETAIN DEVICE EVALUATION AS THE LOT NUMBER OF THE COMPLAINT SAMPLE WAS NOT PROVIDED. ROOT CAUSE: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS PRODUCT COMPLAINT. THERE WAS ABSOLUTELY NO INFORMATION PROVIDED TO REX MEDICAL REGARDING THIS CASE AND SUBSEQUENT PRODUCT COMPLAINT FOR A THOROUGH INVESTIGATION TO BE PERFORMED BY REX MEDICAL PERSONNEL.

Description of Event or Problem · 1

ON (B)(6) 2012, A DISTRIBUTION SALES REPRESENTATIVE WAS INFORMED THAT A PATIENT, WHOM HAD AN OPTION IVC FILTER PLACED IN TIME, EXPERIENCED A MASSIVE PE AND PASSED AWAY. THE FILTER WAS REPORTED TO BE STRAIGHT IN THE CAVA WITH NO THROMBUS IN IT OR NONE HAD COLLECTED NEAR THE HOOK AREA. THE AUTOPSY SHOWED THAT THE THROMBUS IN THE LOWER EXTREMITIES, WHICH WAS PRESENT WHEN THE FILTER WAS PLACED, WAS NO LONGER PRESENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OPTION RETRIEVABLE VENA CAVA FILTER	VENA CAVA FILTER	DTK	REX MEDICAL, L.P.	352506070	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	51 YR		Death