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

Catalog Number RF048F

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

Patient Problems Abdominal Pain (1685); Chest Pain (1776); Palpitations (2467)

Event Date 04/09/2008

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: hull, j.E., han, j., & giessel, g.M.(2008).Retrieval of the recovery filter after arm perforation, fracture, and migration to the right ventricle.Journal of vascular and interventional radiology, 19(7), 1107¿1111.Doi: 10.1016/j.Jvir.2008.03.011.(b)(4).

Event Description

It was reported in an article in the journal of vascular and interventional radiology (jvir) titled " retrieval of the recovery filter after arm perforation, fracture, and migration to the right ventricle " that several weeks after filter placement, computed tomography (ct) demonstrated that the 3 filter arms and one lower limb of the filter had penetrated the inferior vena cava (ivc).Two years later, the patient presented with right-sided abdominal and chest pain; current ct demonstrated that 2 of the perforating arms had fractured and migrated to the right ventricle requiring an additional intervention to remove the filter and the migrated arm with a resolution of chest pain and palpitation.

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: hull, j.E., han, j., & giessel, g.M.(2008).Retrieval of the recovery filter after arm perforation, fracture, and migration to the right ventricle.Journal of vascular and interventional radiology, 19(7), 1107¿1111.Doi: 10.1016/j.Jvir.2008.03.011.H10: b2, g4, h6 (patient: 2132, 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.- attachment: [2009 - hull, j - bard recovery filter - evaluation.Pdf].

Event Description

It was reported in an article in the journal of vascular and interventional radiology (jvir) titled " retrieval of the recovery filter after arm perforation, fracture, and migration to the right ventricle " that several weeks after filter placement, computed tomography (ct) demonstrated that the 3 filter arms and one lower limb of the filter had penetrated the inferior vena cava (ivc).Two years later, the patient presented with right-sided abdominal and chest pain; current ct demonstrated that 2 of the perforating arms had fractured and migrated to the right ventricle requiring an additional intervention to remove the filter and the migrated arm with a resolution of chest pain and palpitation.

• Brand Name: RECOVERY FILTER
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9878833
• MDR Text Key: 185227915
• Report Number: 2020394-2020-02011
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K031328
• 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

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: RF048F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 62 YR