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

Catalog Number MD800F

Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

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

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided for nine out of fourteen malfunctions; therefore, a lot history review was performed.The samples were not returned to the manufacturer for evaluation; however medical records were received for thirteen malfunctions and one malfunction also provided images.The investigation for the 12 of the malfunctions is confirmed for perforation.One malfunction was confirmed for perforation and unconfirmed for tilt.For the remaining malfunction, the investigation is inconclusive as no objective evidence was provided for review.Based upon the available information, the definitive root cause for these malfunctions were unknown.The devices were labeled for single use.(corporate lot no: gfwb4324, gfxc3780, gfxc3640, gfxc3623, gfwj1313, gfxd3859, unknown).

Event Description

This report summarizes fourteen malfunctions.A review of the reported information indicated that model md800f vena cava filter allegedly experienced perforation.This information was received from various sources.All the fourteen malfunctions involves patients with no patient consequences.Thirteen of the patients ranged from 32-86 years of age and three patients' weights ranged from 169-325 lbs.Of the reported patients, four were male and eight were female.The remaining patients' age, weight, and gender were not provided.

Manufacturer Narrative

H10: one the reported 13 malfunctions was reassessed and determined to be a serious injury reported under emdr 2020394-2021-80563.H10: the lot number was provided for ten out of thirteen malfunctions; therefore, a lot history review was performed.The samples were not returned to the manufacturer for evaluation; however medical records were received for thirteen malfunctions and one malfunction also provided images.The investigation for the 11 of the malfunctions is confirmed for perforation.One malfunction was confirmed for perforation and unconfirmed for tilt.For the remaining malfunction, the investigation is confirmed for perforation and inconclusive for tilt.Based upon the available information, the definitive root cause for these malfunctions were unknown.The devices were labeled for single use.H10: d4 (corporate lot no: gfwb4324, gfxc3780, gfxc3640, gfxc3623, gfwj1313, gfxd3859, gfwd3716, unknown).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.

Event Description

This report summarizes 13 malfunctions.A review of the reported information indicated that model md800f vena cava filter allegedly experienced perforation.This information was received from various sources.All the 13 malfunctions involves patients with no patient consequences.Thirteen of the patients ranged from 32-86 years of age and three patients' weights ranged from 169-325 lbs.Of the reported patients, four were male and seven were female.The remaining patients' age, weight, and gender were not provided.

Event Description

This report summarizes 13 malfunctions.A review of the reported information indicated that model md800f vena cava filter allegedly experienced perforation.This information was received from various sources.All the 13 malfunctions involves patients with no patient consequences.Thirteen of the patients ranged from 32-86 years of age and three patients weights ranged from 169-325 lbs.Of the reported patients, four were male and seven were female.The remaining patients' age, weight, and gender were not provided.

Manufacturer Narrative

H10: of the reported 14 reported malfunctions, one was reassessed and determined to be a serious injury reported under emdr 2020394-2021-80563.H10: the lot number was provided for 10 out of remaining 13 malfunctions; therefore, lot history reviews were performed.The samples were not returned to the manufacturer for evaluation; however medical records were received for 13 malfunctions and two malfunctions also provided images.The investigation for 10 malfunctions is confirmed for perforation.For one malfunction tilt (a150202) code was added additionally and the investigation is confirmed for perforation and tilt.For one malfunction tilt (a150202) code was added additionally and the investigation is confirmed for perforation.However, the investigation is inconclusive for tilt.For remaining one malfunction tilt (a150202) code was added additionally and the investigation is confirmed for the perforation.However, the investigation is unconfirmed for the filter tilt.Based upon the available information, the definitive root cause for these malfunctions were unknown.The devices were labeled for single use.H10: d4 (corporate lot no: gfwb4324, gfwd3716, gfxc3780, gfxc3640, gfxc3623, gfwj1313, gfxd3859, unknown), g3.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: MERIDIAN FILTER
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10304133
• MDR Text Key: 199838527
• Report Number: 2020394-2020-04767
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: MD800F
• Device Lot Number: GFWD3715, GFVL0132, GFVI0347
• Date Manufacturer Received: 09/30/2021
• Patient Sequence Number: 1