FDA Adverse Event Injury Summary report: N

TRAPEASE UNKNOWN FILTER

MDR report key: 686993 · Received March 9, 2006

Report

Report Number
9610978-2006-00080
Event Type
Injury
Date Received
March 9, 2006
Report Date
March 9, 2006
Manufacturer
CORDIS RODEN
Product Code
DTK
Removal / Correction Number
NA
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
WV, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

AS REPORTED IN A JOURNAL ARTICLE, A TRAPEASE VENA CAVA FILTER THAT WAS PLACED IN THIS TRAUMA PATIENT WAS FOUND TO HAVE MIGRATED AND TILTED TO A LEVEL JUST ABOVE TEH RENAL VEINS, APPROXIMATELY ONE MONTH FOLLOWING INSERTION. THIS PATIENT WAS PRESENTED TO THE EMERGENCY ROOM AFTER SUSTAINING A GUNSHOT WOUND TO HIS RIGHT FLANCK REGION. AFTER INITIAL STABILIZATION, HE WAS TAKEN TO THE OPRATING ROOM FOR AN EMERGENT EXPLORATORY LAPAROTOMY. HE HAD A LIVE LACERATION, A TRANSVERSE COLON TRANSACTION, AND A CECAL INJURY SECONDARY TO THE BLAST EFFECT. A RIGHT HEMIGCOLECTOMY WITH RIGHT PRIMARY ANASTOMOSIS WAS PERFORMED, AS WELL AS DEBRIDEMENT OF HIS RIGHT FLANCK WOUND. HIS INJURIES LIMITED MOBILIZATION, AND POSTOPERATIVELY HE DEVELOPED BILATERAL POPLITEAL DEEP VEIN THROMBOSIS (DVT) WHILE ON LOW MOLECULAR HEPARIN PROPHYLAXIX. HE WAS THEN STARTED ON THERAPEUTIC DOSES OF LOW MOLECULAR HEPARIN PROPHYLAXIX. HE WAS THEN STARTED ON THERAPEUTIC DOSED OF LOW MOLECULAR WEIGHT HEPARIN. HOWEVER, WHILE ON THERPEUTIC DOSES, THE PATIENT DEVELOPED DYSPNEA AND DECREASED OXYGEN SATURATION LEVELS. A SUBSEQUENT COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) OF THE PULMONARY ARTERIES SHOWED BILATERAL PULMONARY EMBOLISM (PE). THE PATIENT WAS IMMEDIATELY HEPARNIZED, AND THE DECISION WAS MADE TO PLACE AN INFERIOR VENA CAVA (IVC) FILTER. A TRAPEASE IVC FILTER WAS PLACED VIA THE LEFT SUBCLAVIAN USING THE SELDINGER TECHNIQUE. THE FILTER WAS DEPLOYED USING DIRECT FLUOROSCOPY AT THE JUNCTION OF THE SECOND AND THIRD LUMBAR VERTEBRAL BODIES. IVC DIMENSIONS WERE MEASURED WITH TWO VENOGRAMS AND THE VENA CAVA MEASURED 20MM. THE VENOGRAMS DID NOT REVEAL ANY EVIDENCE FOR VENA CAVAL DUPLICATION, THROMBOSIS, OR OTHER ANATOMIC ANOMALY. A VENOGRAM WAS ALSO PERFORMED POST-PROCEDURE TO CONFIRM DEPLOYMENT OF THE FILTER BELOW THE RENAL VEINS. THERE WAS NO EVIDENCE OF MIGRATION OR TILT. A PLAIN ABDOMINAL X-RAY WAS TAKEN AND ALSO CONFIRMED PLACEMENT, LACK OF MIGRATION, AND ABSENCE OF FILTER TILT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 TRAPEASE UNKNOWN FILTER THROMBECTOMY SYSTEMS DTK CORDIS RODEN NA UNK

Patients

Seq Age Sex Outcome Treatment
1 31 YR Life Threatening| R