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

For all six devices, lot numbers were provided and lot history reviews were performed.All the six devices were not returned to the manufacturer for evaluation; however, medical records were provided for all malfunctions.For four malfunctions, the investigations are confirmed for perforation of the inferior vena cava.For one malfunction, the investigation is inconclusive for perforation of the inferior vena cava.For the remaining one malfunction, the company is still investigating the issue at this time.Based upon the available information, the definitive root cause is unknown.The devices are labeled for single use.(corporate lot no: gfxh2774, gfwa4157, gfvk0268).

Event Description

This report summarizes six malfunctions.A review of the reported information indicated that model md800f vena cava filter allegedly experienced patient device interaction problem.This information was received from various sources.This malfunction involved all six patients with no consequences.Six patients' ages were reported to be between 53-75 years and two patients¿ weight were reported to be between 195-223 lbs, two patients were reported as male, and four patients were reported as female.All other patient details were not provided.

Manufacturer Narrative

H10: for all six devices, lot numbers were provided and lot history reviews were performed.All the six devices were not returned to the manufacturer for evaluation; however, medical records were provided for all malfunctions.For five malfunctions, the investigations are confirmed for perforation of the inferior vena cava.For one malfunction, the investigation is inconclusive for perforation of the inferior vena cava.Based upon the available information, the definitive root cause is unknown.The devices are labeled for single use.H10: d4 (corporate lot no: gfxh2774, gfwa4157, gfvk0268).

Event Description

This report summarizes six malfunctions.A review of the reported information indicated that model md800f vena cava filter allegedly experienced patient device interaction problem.This information was received from various sources.This malfunction involved all six patients with no consequences.Six patients' ages were reported to be between 53-75 years and two patients¿ weight were reported to be between 195-223 lbs, two patients were reported as male, and four patients were reported as female.All other patient details were not provided.

• 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: 11225248
• MDR Text Key: 228844018
• Report Number: 2020394-2021-80125
• 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
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• 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: GFXC3391,GFXE3375,GFXI2510
• Date Manufacturer Received: 03/31/2021
• Patient Sequence Number: 1