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

Catalog Number UNKNOWN G2

Device Problems Migration or Expulsion of Device (1395); Obstruction of Flow (2423); Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Material Deformation (2976); Activation Failure (3270)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the malfunctions was not provided; therefore, a lot history review could not be performed.The devices have not been returned for evaluation; therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.(b)(4).

Event Description

This report summarizes 90 malfunctions.A review of the reported information indicated that an unknown vena cava filter model allegedly experienced 38 with perforation, 22 with tilt, 16 with caudal migration, 1 with cranial migration, 3 with inferior vena cava (ivc) occlusion, 3 with bent filter limb, 5 with compressed filter limb, 1 that failed to expand, and 2 with filter fracture, out of 139 patients.This information was received from one source.Each malfunction involved a patient with no known impact to the patient.The patient¿s age, weight, and gender were not provided.

Event Description

This report summarizes 91 malfunctions.A review of the reported information indicated that an unknown g2 vena cava filter allegedly experienced perforation, tilt, caudal migration, cranial migration, inferior vena cava (ivc) occlusion, bent filter limb, compressed filter limb, failed to expand, and filter fracture.This information was received from one source.Each malfunction involved a patient with no known impact to the patient.The patient¿s age, weight, and gender were not provided.

Manufacturer Narrative

H10: the lot number for all the malfunctions were not provided; therefore, lot history reviews could not be performed.The devices have not been returned for evaluation; therefore, the investigation is inconclusive for all malfunctions as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.The devices are labeled for single use.Zhu, x., tam, m.D., bartholomew, j., newman, j.S., sands, m.J., & wang, w.(2011).Retrievability and device-related complications of the g2 filter: a retrospective study of 139 filter retrievals.Journal of vascular and interventional radiology, 22(6), 806¿812.Doi: 10.1016/j.Jvir.2011.01.430.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: G2 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 NY 12804
• Manufacturer Contact: brett curtice ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032772
• MDR Report Key: 9969650
• MDR Text Key: 189353820
• Report Number: 2020394-2020-02885
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: UNKNOWN G2
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/16/2020
• Supplement Dates Manufacturer Received: 06/30/2022
• Supplement Dates FDA Received: 07/26/2022
• Type of Device Usage: A
• Patient Sequence Number: 1