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

Catalog Number RF048F

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

Patient Problem Abdominal Pain (1685)

Event Date 09/06/2003

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: a 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.Post placement film demonstrated a bard recovery filter in good position at the level of the l1 vertebral body.Few days post filter deployment, the patient presented with complaint of abdominal pain.Subsequently abdomen 1 view portable revealed inferior vena cava filter was in the region overlying the inferior vena cava.Approximately fourteen years and six months later, computerized tomography (ct) revealed that multiplanar reformations were rendered.There are two right renal veins.The inferior vena cava filter dome was located superior to the more inferior of the two veins and just below the more superior of the two veins.The filter dome was tilted to the right and posteriorly nearly contacting the posterior caval wall.Multiple filter struts penetrated the inferior vena cava by up to 7 mm mostly posteriorly and to the right.The struts did not penetrate or contact the adjacent renal artery or vein or aorta.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc) and filter tilt.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.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 some time post filter deployment, the patient allegedly experienced filter perforation, migration, and tilting.There were no reported attempts made to retrieve the filter.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 ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 11249989
• MDR Text Key: 229291721
• Report Number: 2020394-2021-80137
• 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: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• 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
• Date Manufacturer Received: 01/08/2021
• 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: IMIPENEM, AMIKACIN, ZYVOX, DURAGESIC PATCH; INDOCIN, ZANTAC, ZINC OXIDE
• Patient Outcome(s): Other
• Patient Age: 44 YR