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

Catalog Number UNKNOWN FILTER

Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001); Migration (4003)

Patient Problem Abdominal Pain (1685)

Event Date 01/29/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the device was not returned for evaluation.Medical records were not provided.The investigation is inconclusive for the alleged perforation of inferior vena cava (ivc) as no objective evidence has been provided to confirm any alleged deficiency with the filter.The definitive root cause could not be determined based upon available information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.The information provide by bd represents all 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 deep vein thrombosis.At some time post filter deployment, it was alleged that the filter perforated.The patient experienced abdominal pain; however, the current status of the patient is unknown.

Manufacturer Narrative

H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: g2, g3.H11: b3, d1, d4(medical device catalog number), h6(device, result and conclusion).H11: section a through f: the information provide by bd represents all 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.H3 other text : device not returned.

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 perforated.The patient experienced abdominal pain; however, the current status of the patient is unknown.

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 perforated.The patient experienced abdominal pain; however, the current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Bard unknown filter was deployed in the infrarenal inferior vena cava at the l2-l3 level for a patient with an unknown indication.Post filter deployment, computed tomography of abdomen and pelvis show that through the vein approach, a bard filter was deployed in the infrarenal inferior vena cava at the l2-l3 level.The filter was tilted posteriorly, with the filter apex contacting, and likely embedded, in the posterior caval wall just below the renal veins.Five of the filter¿s six legs (primary struts) perforate the wall of the inferior vena cava, with direct impingement on overlying small bowel anteriorly and adjacent aortic wall medially.One secondary strut arm also perforates the caval wall anteromedially.No fractures or missing components are identified.The caval wall was thickened posteriorly at strut and apex contact points.No caval thrombosis or clot within the filter.Around two months later, computed tomography of abdomen was performed for inferior vena cava filter evaluation which showed there was a filter in the inferior vena cava.The filter tilts posteriorly with the tip lying against the posterior wall of the inferior vena cava at the level of the renal veins.The tines extend through the wall of the inferior vena cava.Around one and a half months later, the review of medical records and imaging files was performed which revealed a bard filter was deployed in the infrarenal inferior vena cava at the l2-l3 level.The filter was tilted posteriorly (20 degrees), with the filter apex contacting, and likely embedded, in the posterior caval wall just below the renal veins.Four of the filter¿s six legs (primary struts) perforate the wall of the inferior vena cava, with direct impingement overlying small bowel anteriorly and adjacent aortic wall medially.Two of the filter¿s six arms (secondary struts) also perforate the caval wall.Two filter arms have fractured and are missing from vicinity of filter location.One of the resulting strut fragments has embolized/migrated into the inferior pole of the patient's lower lung and the other was in the inferior pole of the patient's right kidney.The caval wall was thickened posteriorly at strut and apex contact points.No caval thrombosis or clot within the filter was noted.Therefore, the investigation is confirmed for the alleged perforation of the inferior vena cava, filter tilt, filter limb detachment.However, the investigation is inconclusive for filter migration.A definitive root cause could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.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.

• 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
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 11862876
• MDR Text Key: 252192304
• Report Number: 2020394-2021-01091
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• 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,Followup,Followup
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• 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
• Date Manufacturer Received: 11/29/2021
• 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: ASPIRIN, SODIUM CHLORIDE, MEROPENEM; ASPIRIN, SODIUM CHLORIDE, MEROPENEM; DAPTOMYCIN AND HEPARIN FLUSH; DAPTOMYCIN AND HEPARIN FLUSH; ONDANSETRON, HYDROCODONE, COUMADIN; ONDANSETRON, HYDROCODONE, COUMADIN; VICODIN, AMOXICILLIN, ZYVOX, SILVER NITRATE; VICODIN, AMOXICILLIN, ZYVOX, SILVER NITRATE
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 115 KG
• Patient Race: White