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

Catalog Number RF048F

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); Great Vessel Perforation (2152)

Event Date 04/03/2018

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 were not provided for review.Medical records were provided and reviewed.Approximately 12 years post deployment, a ct showed a chronic clot in aorta and right common iliac artery.The filter strut was embedded into the aortic wall.Same day, the retroperitoneum was opened from renal vein to just past the aortic bifurcation of the two iliac arteries.A 4 fogarty embolectomy catheter was then passed down the common iliac artery and the clot comes out and the strut was coming out of vena cava and then it was pulled out of the aorta.Approximately five days later, an abdominal kub was performed which revealed ivc filter remained in place.Therefore, the investigation can be confirmed for perforation of the ivc and limb detachment.However, the investigation is inconclusive for retrieval difficulties as there is no evidence of difficulty in removing the ivc filter in the provided medical records.Based upon the available information, the definitive root cause is unknown.Labeling review:the current ifu (instructions for use) states: warnings: filter fracture is a known complication of vena cava filters.Potential complications: perforation of other acute or chronic damage of the ivc wall.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/pulmonary embolism.At some time post filter deployment, it was alleged that a filter limb detached and perforated a vein.Subsequently, vein bypass was performed.During an open abdominal procedure an attempt to retrieve the filter was unsuccessful; however, the detached limb was successfully retrieved.The patient reportedly experienced infection post vein bypass; however, the current status of the patient is unknown.

• Brand Name: RECOVERY FILTER SYSTEM
• 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 ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8578728
• MDR Text Key: 143993288
• Report Number: 2020394-2019-00541
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031328
• 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: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF048F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/08/2019
• Initial Date FDA Received: 05/03/2019
• 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: GABAPENTIN AND MULTIPLE VITAMINS
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Weight: 99