MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. RECOVERY FILTER SYSTEM; 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 Pulmonary Embolism (1498); Chest Pain (1776); Dyspnea (1816)

Event Date 04/08/2010

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.(b)(4).Journal article citation: desjardins, b., kamath, s.H., & williams, d.(2010).Fragmentation, embolization, and left ventricular perforation of a recovery filter.Journal of vascular and interventional radiology, 21(8), 1293¿1296.Doi: 10.1016/j.Jvir.2010.04.019.

Event Description

It was reported in an article in the journal of vascular and interventional radiology (jvir) titled " fragmentation, embolization, and left ventricular perforation of a recovery filter " that 3 years after filter placement, 2 filter struts detached and embolized; one to the right middle pulmonary artery and another perforated the left ventricular wall with tip resting near diaphragm causing pericardial effusion and subsequent chronic pulmonary emboli.Thoracotomy, cardiopulmonary bypass, cardioplegic arrest was required to remove the fragment from heart and 3 days later, another fragment was removed under interventional radiology.The patient recovered well after surgery.

Event Description

It was reported in an article in the journal of vascular and interventional radiology (jvir) titled " fragmentation, embolization, and left ventricular perforation of a recovery filter " that 3 years after filter placement, 2 filter struts detached and embolized; one to the right middle pulmonary artery and another perforated the left ventricular wall with tip resting near diaphragm causing pericardial effusion and subsequent chronic pulmonary emboli.Thoracotomy, cardiopulmonary bypass, cardioplegic arrest was required to remove the fragment from heart and 3 days later, another fragment was removed under interventional radiology.The patient recovered well after surgery.

Manufacturer Narrative

H10: manufacturing review: a device history record (dhr) review was not performed as the lot number was unknown.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for the alleged failure.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.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: g4, h6 (patient: 3271, 2513), h6 (conclusion).H11: d1, h6 (device).Journal article citation: desjardins, b., kamath, s.H., & williams, d.(2010).Fragmentation, embolization, and left ventricular perforation of a recovery filter.Journal of vascular and interventional radiology, 21(8), 1293¿1296.Doi: 10.1016/j.Jvir.2010.04.019 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: [2010 - desjardins, b - fragmentation, emboliza.Pdf].

• 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
• MDR Report Key: 9930274
• MDR Text Key: 187593930
• Report Number: 2020394-2020-02427
• 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: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• 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: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COUMADIN; COUMADIN; LOVENOX; LOVENOX; NITROGLYCERINE TABLET; NITROGLYCERINE TABLET
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 47 YR