FDA Adverse Event Injury Summary report: N

TITANIUM GREENFIELD VENA CAVA FILTER

MDR report key: 6390 · Received August 31, 1993

Report

Report Number: 6390
Event Type: Injury
Date Received: August 31, 1993
Date of Event: July 15, 1993
Report Date: July 23, 1993
Manufacturer: MEDI TECH BOSTON SCIENTIFIC CORPORATION
Product Code: LWT
Adverse Event: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

PATIENT WAS SCHEDULED FOR A VENA CAVA FILTER. ON INSERTION FILTER FAILED TO OPEN AND MIGRATED TO THE PULMONARY ARTERY. IT BECAME NECESSARY TO PLACE PATIENT ON BYPASS AND PERFORM MEDIAN STERNOTOMY TO RETREIVE FILTERDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: MECHANICAL PROBLEM, TELEMETRY FAILURE, OTHER. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TITANIUM GREENFIELD VENA CAVA FILTER Implant		LWT	MEDI TECH BOSTON SCIENTIFIC CORPORATION		113853

Patients

Seq	Age	Sex	Outcome	Treatment
1	42 YR		Required Intervention