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

Catalog Number UNKNOWN FILTER

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2019

Event Type  Death  

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 not provided.The investigation is inconclusive 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.

Event Description

It was reported through the litigation process that some time post vena cava filter deployment the patient expired.There was no specific device malfunction reported that may or may not have caused or contributed to the patient¿s death.The cause of the patient¿s death was not provided.No other pertinent patient, device or medical information was provided leading up to or surrounding the event.

Manufacturer Narrative

H10: 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.After sometimes post deployment, the patient presented with back pain.On the same day, an x-ray spine lumbar minimum 4 views showed that a vena cava filter was noted.After six years and two months, a computed tomography (ct) abdomen and pelvis without contrast demonstrated that an inferior vena cava filter was seen.The tip of the inferior vena cava filter was seen in the middle part of the inferior vena cava and just inferior to the right renal vein.Penetration of the leads of the inferior vena cava filter was noted to the surrounding fat, the penetration measured 9 mm.One of the anterior leads penetrated to the duodenal wall.Therefore, the investigation is confirmed for the alleged perforation of the inferior vena cava.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: g2,g3,h6(method, conclusion).H11: b5,h6(device, result).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 in a patient after being diagnosed with unknown medical complication.At some time post filter deployment, a computed tomography (ct) abdomen and pelvis without contrast revealed that the filter struts penetrated to the duodenal wall.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly expired.

• Brand Name: VENA CAVA FILTER
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10231581
• MDR Text Key: 197537567
• Report Number: 2020394-2020-04223
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• 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: 09/24/2021

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: UNKNOWN FILTER
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/16/2020
• Initial Date FDA Received: 07/06/2020
• Supplement Dates Manufacturer Received: 09/20/2021
• Supplement Dates FDA Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIORESAL, BETHANECHOL AND GABAPENTIN; TAMSULOSIN AND ACETAMINOPHEN-HYDROCODONE
• Patient Outcome(s): Death
• Patient Age: 64 YR
• Patient Weight: 81