MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ECLIPSE FILTER SYSTEM - FEMORAL; VENA CAVA FILTER

Catalog Number EC500J

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616); Extrusion (2934); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); No Consequences Or Impact To Patient (2199)

Event Date 04/20/2017

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for filter perforation, tilt and migration post filter deployment as no objective evidence has been provided to confirm any alleged deficiency with the filter.Based upon the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported through the litigation process that some time post vena cava filter deployment the filter perforated, tilted, and migrated.There were no reported attempts made to retrieve the filter.The status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately four years two months of post deployment, the patient presented with history of abdominal pain and a computerized tomography-abdomen without contrast was performed which showed that the filter was tilted to the right with its cone lying on the right lateral wall of the inferior vena cava possibly embedded within it.The legs of the filter had penetrated through the wall of the inferior vena cava into the pericaval/mesenteric fat.Therefore, the investigation is confirmed for filter tilt and perforation of the inferior vena cava (ivc).However, the investigation is inconclusive for filter migration.Based upon the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.H10: (expiration date: 10/2015).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported through the litigation process that a vena cava filter was placed after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that the filter migrated, tilted, struts perforated and embedded in wall of the inferior vena cava.The device has not been removed and there were no reported attempts made to retrieve the filter.The current status of the patient is unknown.

• Brand Name: ECLIPSE FILTER SYSTEM - FEMORAL
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7555133
• MDR Text Key: 109623600
• Report Number: 2020394-2018-00755
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K093659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EC500J
• Device Lot Number: GFWI3176
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COUMADIN, NITROGLYCERIN, LOVENOX, CYMBALTA; LEVOTHYROXINE; LORTAB, NITROSTAT, VALIUM, AMITRIPTYLINE; METFORMIN, CARISOPRODOL, DIPYRIDAMOLE; SERTRALINE, CRESTOR, DUO NEB, METOPROLOL
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 102