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

Catalog Number EC500F

Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problem Abdominal Pain (1685)

Event Date 05/11/2017

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: the device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately four years post filter deployment, patient presented with abdominal pain.Subsequently next month, wound debridement and wound vac placement procedure was performed.Approximately two years later, patient again presented with abdominal pain.Approximately three months later, patient was evaluated for shortness of breath.Approximately five months later, computed tomography revealed inferior vena cava filter was positioned infrarenal at the level, there was a slight apex right tilt and all 6 primary centering struts had perforated the inferior vena cava wall with impingement on overlying small bowel, underlying vertebral body and the aorta.Some of the secondary/centering struts had perforated the inferior vena cava as well.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc).However, the investigation is inconclusive for filter tilt.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.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis.At some time post filter deployment, it was alleged that the filter tilted, struts perforated and the patient reportedly experienced abdominal pain.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
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10486852
• MDR Text Key: 205461888
• Report Number: 2020394-2020-05543
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EC500F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CLARITHROMYCIN, FAMOTIDINE, HYDROCODONE; CODEINE, HYDROXYZINE HCL, HYDROXYZINE PAMOATE; DEXLANSOPRAZOIE, ALBUTEROL, HYDROMORPHONE; DIPHENHYDRAMINE, CLINDAMYCIN HCL; GLUCOVANCE, CLONAZEPAM, LEXAPRO; MOXIFLOXACIN, ESCITALOPRAM, GLYBURIDE; NALBUPHINE, SULFAMETHOXAZOLE, TEMAZEPAM; NEXIUM, ATENOLOL, PRAVASTATIN, HYDROCODONE; NICOTINE, LEVALBUTEROL, FUROSEMIDE, MEPERIDINE; NIZATIDINE, ARISTARIL, DICYCLOMINE HCL; OXYCODONE, PENICILLINS, SULFA; PHENERGAN, LEVOTHYROXINE, GLUCOVANCE; PROTONIX, GASX, MIRTAZAPINE, TRAMADOL; TRIMETHOPRIM, IODINATED CONTRAST, MEPERIDINE HCL
• Patient Outcome(s): Other
• Patient Age: 68 YR