MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SIMON NITINOL FILTER SYSTEM; VENA CAVA FILTER

Catalog Number 2220J

Device Problems Malposition of Device (2616); 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 1 out of 2 reported malfunctions, therefore, lot history review was performed.The product catalog number for one malfunction was updated as unknown snf.The devices were not returned to the manufacturer for evaluation/inspection; however medical records were provided and reviewed for both malfunctions.Therefore, the investigation for the two reported malfunctions were confirmed for alleged perforation of the inferior vena cava and filter tilt.Based on the available information, the definitive root cause is unknown.The devices are labeled for single use.

Event Description

This report summarizes two malfunctions.A review of the reported information indicates that model 2220j vena cava filter allegedly perforated and tilted.The information was received from various source.Both the malfunctions were involved patients with no reported consequences.Of the reported malfunctions, two female patients ages were ranged from 52 to 67 years old; however, the weights were not provided.

Manufacturer Narrative

H10: the lot number was provided for 1 out of 2 reported malfunctions , therefore, lot history review was performed.The devices were not returned to the manufacturer for evaluation/inspection; however medical records were provided and reviewed for both malfunctions.For 1 of the 2 malfunctions, the investigation is confirmed for perforation and tilt.The remaining one malfunction was identified for perforation, tilt and migration based on medical record review.Based on the available information, the definitive root cause is unknown.The devices are labeled for single use.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 two malfunctions.A review of the reported information indicates that model 2220j vena cava filter allegedly perforation and tilt.The information was received from various source.Both the malfunctions were involved patients with no reported consequences.Of the reported malfunctions, two female patients ages were ranged from 52 to 67 years old; however, the weights were not provided.

• Brand Name: SIMON NITINOL FILTER SYSTEM
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11224326
• MDR Text Key: 228843599
• Report Number: 2020394-2021-80122
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2220J
• Device Lot Number: GFQL4085,UNKNOWN
• Initial Date Manufacturer Received: 12/31/2020
• Initial Date FDA Received: 01/25/2021
• Supplement Dates Manufacturer Received: 03/30/2021
• Supplement Dates FDA Received: 03/31/2021
• Patient Sequence Number: 1