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

Catalog Number UNKNOWN FILTER

Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problems Pulmonary Embolism (1498); Abdominal Pain (1685); Atrial Fibrillation (1729)

Event Date 02/09/2008

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Journal article citation: hermsen, j.L., ibele, a.R., faucher, l.D., nale, j.K., schurr, m.J., & kudsk, k.A.(2008).Retrievable inferior vena cava filters in high-risk trauma and surgical patients: factors influencing successful removal.World journal of surgery, 32(7), 1444¿1449.Doi: 10.1007/s00268-007-9462-z.

Event Description

It was reported in an article from the world journal of surgery titled " retrievable inferior vena cava filters in high-risk trauma and surgical patients: factors influencing successful removal " that 3 patients experienced nonfatal pulmonary embolism (pe) on 3,5 and 39 days after filter placement and received anticoagulation therapy.One patient experienced intractable abdominal pain as the filter strut was penetrating the duodenum, therefore, the filter was removed.One patient experienced post removal related atrial fibrillation requiring cardioversion with propafenone.The status of the patients was not provided.

Manufacturer Narrative

H10: as the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Journal article citation: hermsen, j.L., ibele, a.R., faucher, l.D., nale, j.K., schurr, m.J., & kudsk, k.A.(2008).Retrievable inferior vena cava filters in high-risk trauma and surgical patients: factors influencing successful removal.World journal of surgery, 32(7), 1444¿1449.Doi: 10.1007/s00268-007-9462-z.H10: b2, g4, h6 (conclusions).H11: h6 (device).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 in an article from the world journal of surgery titled " retrievable inferior vena cava filters in high-risk trauma and surgical patients: factors influencing successful removal " that 3 patients experienced nonfatal pulmonary embolism (pe) on 3,5 and 39 days after filter placement and received anticoagulation therapy.One patient experienced intractable abdominal pain as the filter strut was penetrating the duodenum, therefore, the filter was removed.One patient experienced postremoval related atrial fibrillation requiring cardioversion with propafenone.The status of the patients was not provided.

• Brand Name: NITNOL FILTER
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9872236
• MDR Text Key: 185228838
• Report Number: 2020394-2020-01966
• 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: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 07/27/2020

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: 02/26/2020
• Initial Date FDA Received: 03/24/2020
• Supplement Dates Manufacturer Received: 07/24/2020
• Supplement Dates FDA Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention