FDA Adverse Event Death Summary report: N

VENATECH LP FILTER

MDR report key: 6088731 · Received November 9, 2016

Report

Report Number: 9612452-2016-00042
Event Type: Death
Date Received: November 9, 2016
Date of Event: August 14, 2016
Report Date: November 8, 2016
Manufacturer: B.BRAUN MEDICAL SAS - OWNER
Product Code: DTK
UDI-DI: 04038653918164
PMA / PMN Number: K010485
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

BATCH HISTORY REVIEW: THE MANUFACTURING FILE OF THE INVOLVED BATCH WAS REVIEWED. THE BATCH IS COMPLIANT WITH OUR SPECIFICATIONS AND NO ABNORMALITY WAS DETECTED. NO OTHER COMPLAINT WAS REPORTED ON THIS BATCH OF VENA CAVA FILTERS SOLD SINCE JULY 2014. INVESTIGATION: EITHER PRECISE INFORMATION ABOUT THE INCIDENT NOR X-RAY PICTURES ARE AVAILABLE FOR ANALYSIS. NO THOROUGH INVESTIGATION CAN BE PERFORMED.

Description of Event or Problem · 1

THE REPORTER CALLED ON BEHALF OF HER LATE HUSBAND WHO PASSED AWAY. THE PATIENT WAS IMPLANTED WITH A VENA CAVA FILTER TO PREVENT BLOOD CLOT TO HIS HEART. AFTER IMPLANTATION HE STARTED EXPERIENCING DISCOLORATION IN HIS EXTREMITIES AND WAS HOSPITALIZED. HE WAS LATER TAKEN TO A NURSING HOME FOR REHABILITATION. ACCORDING TO THE REPORTER DURING HIS STAY AT THE NURSING HOME HIS DOCTOR NEVER VISITED AND HIS HEALTH DETERIORATED. HE WAS LATER TRANSFERRED TO A HOSPITAL WHERE HE WAS DIAGNOSED WITH GANGRENE. ONE OF HIS FEET WAS AMPUTATED. THE DOCTORS AT THE HOSPITAL LATER DECIDED TO AMPUTATE THE OTHER FOOT. AFTER THE SECOND SURGERY HE HAD A MASSIVE STROKE AND DIED. CALLER BELIEVED THE STENT MAY HAVE CONTRIBUTED TO HIS DEATH.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
741566	VENATECH LP FILTER	VENA CAVA FILTER SYSTEM	DTK	B.BRAUN MEDICAL SAS - OWNER	31335	N142628V	04038653918164

Patients

Seq	Age	Sex	Outcome	Treatment
1			Death