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); Difficult to Remove (1528); Obstruction of Flow (2423); Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

As the lot numbers for all 308 malfunctions were not provided, a lot history review could not be performed.Out of the 308 reported malfunctions, the devices were not returned to the manufacturer for evaluation; therefore, the investigations are inconclusive due to no sample return.The definitive root cause for the reported events is unknown.The devices are labeled for single use.(b)(4).

Event Description

This report summarizes 308 malfunctions.A review of the reported information indicated that model unknown vena cava filter allegedly experienced difficult to remove (29), patient-device incompatibility (104), obstruction of flow (16), detachment of device or device component (8), migration or expulsion of device (80), and malposition of the device (71).This information was received from various sources.Of the 308 malfunctions, all involved patients with no patient consequences.Age, weight, and gender were not provided.

Event Description

This report summarizes 308 malfunctions.A review of the reported information indicated that model unknown g2 vena cava filter allegedly experienced difficult to remove, patient-device incompatibility, obstruction of flow, detachment of device or device component, migration or expulsion of device, and malposition of the device.This information was received from various sources.Of the 308 malfunctions, all involved patients with no patient consequences.Age, weight, and gender were not provided.

Manufacturer Narrative

H10: as the lot numbers for all 308 malfunctions were not provided, a lot history review could not be performed.Out of the 308 reported malfunctions, the devices were not returned to the manufacturer for evaluation; therefore, the investigations are inconclusive due to no sample return.The definitive root cause for the reported events is unknown.The devices are labeled for single use.Zhu, x., tam, m., mclennan, g., sands, m., & wang, w.(2010).Abstract no.3: indications, complications and outcomes of g2 retrievable ivc filters in 765 patients: a single institute experience.Journal of vascular and interventional radiology, 21(2).Doi: 10.1016/j.Jvir.2009.12.144.Damascelli, b., ticha, v., patelli, g., lanocita, r., morosi, c., civelli, e., et all (2011).Use of a retrievable vena cava filter with low-intensity anticoagulation for prevention of pulmonary embolism in patients with cancer: an observational study in 106 cases.Journal of vascular and interventional radiology, 22(9), 1312¿1319.Doi: 10.1016/j.Jvir.2011.04.015.Binkert, c.A., drooz, a.T., caridi, j.G., sands, m.J., bjarnason, h., lynch, f.C.Et all (2009).Technical success and safety of retrieval of the g2 filter in a prospective, multicenter study.Journal of vascular and interventional radiology, 20(11), 1449¿1453.Doi: 10.1016/j.Jvir.2009.08.007.H10: g3.H11: g1, h6 (conclusion).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: 9970106
• MDR Text Key: 189048907
• Report Number: 2020394-2020-02905
• 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

• Date FDA Received: 04/16/2020
• 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
• Date Manufacturer Received: 06/30/2022
• Type of Device Usage: A
• Patient Sequence Number: 1