MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - FEMORAL; VENA CAVA FILTER

Catalog Number RF310F

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Extrusion (2934); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Hematoma (1884); Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for retrieval difficulties, migration of the filter, and perforation of the ivc 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: the current ifu (instructions for use) states: warnings/potential complications: movement, migration or tilt of the filter are known complications of vena cava filters.Perforation or other acute or chronic damage of the ivc wall note: it is possible that complications such as those described in the "warnings", "precautions", or "potential complications" sections of this instructions for use may affect the recoverability of the device and result in the clinician's decision to have the device remain permanently implanted.The information provided by bard 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 bard.

Event Description

It was reported through the litigation process that approximately seven years post filter deployment the filter perforated and migrated.It was further reported that an initial attempt to retrieve the filter was unsuccessful; however, the filter was subsequently removed via an open removal procedure.The status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately seven years later, the patient visited the hospital to consult for the filter removal, the patient recently developed some chest pain and computed tomography (ct) scan was reviewed that the filter appears to be centered well and the inferior vena cava.There was migration of the barbs out of the wall of the cava.None of them have penetrated any vital organs.After two weeks, the patient scheduled for the filter retrieval and the patient recently undergone a computed tomography (ct) scan for moderate mid abdominal pain and the prongs of the filter had eroded through the inferior vena cava wall and into surrounding tissue.The right internal jugular vein was accessed, and the snare were able to grasp the proximal portion of the filter.Several attempts were made to collapsing the filter into the sheath and in manipulating the filter it became dislodged from the wall it migrated somewhat proximally but stayed within the inferior vena cava.It was concerned that with a mobile filter that it could embolize into the heart.Therefore, it was snared and retracted within the sheath as much as possible and removed the sheath bringing the filter up into the superior vena cava.The filter was loosed from the snare at this point and it was lysed well within the inferior vena cava.The sheath come out of the jugular vein and reinserted again.Contrast was injected and the sheath had lodged proximal or at the cephalad portion of the subclavian vein.Several attempts were made to snare the sheath again were unsuccessful.Subsequently a chest portable was performed, and it revealed filter remains overlying the confluence of brachiocephalic veins.Appearance was like the prior fluoroscopy image.Again, the patient was brought back to the operating room at this time for open removal.Fluoroscopy used to locate filter at level of clavicle.Attempts were made to use 14mm balloon from right femoral vein access to push filter further superior in the neck to facilitate access from open cutdown, but filter would not move more distal in vein.Thus, open cutdown was performed, right internal jugular was explored, and the filter was not located.Fluoroscopy was again used at different angles to reveal that filter had been pushed into vertebral vein.Right internal jugular was ligated to facilitate access to right vertebral vein and the filter was pulled out without issue.The pathology report stated that the filter consisting of 12 metal spokes joined at one end in a conical shape.After five days, the patient presented to the hospital with the complaint of swallowing of right neck and pain.A duplex of upper extremity was performed, and it revealed there was a evidence of large area of complex echoes surrounding right jugular vein and involving neck muscles, likely representing post-procedural hematoma measuring approximately 4.1*4.4*9.3cm.Therefore, the investigation is confirmed for alleged filter migration, perforation of the inferior vena cava and retrieval difficulties.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: b5, b7, d4(expiry date: 12/2012).

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with or before bariatric procedure.At some time post filter deployment, it was alleged that the filter struts perforated and migrated.The device was removed via an open chest procedure after an attempted but unsuccessful percutaneous removal procedure.The current status of the patient is unknown.

• Brand Name: G2 FILTER SYSTEM - FEMORAL
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7374279
• MDR Text Key: 103584528
• Report Number: 2020394-2018-00281
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K062887
• 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: 02/23/2021

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: RF310F
• Device Lot Number: GFTK1571
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/09/2018
• Initial Date FDA Received: 03/27/2018
• Supplement Dates Manufacturer Received: 01/26/2021
• Supplement Dates FDA Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CYANOCOBALAMIN, ERGOCALCIFEROL.; MULTIVITAMIN AND FLONASE ALLERGY.
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 180