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

Catalog Number EC500J

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

Each of the five malfunctions had a lot numbers provided, and lot history reviews were performed.Two malfunctions had medical records provided; one investigation confirmed perforation and the other remained inconclusive.The remaining malfunctions did not have devices returned for evaluation; therefore, the investigations are inconclusive for the perforation 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.(lot number: gfua4320, gfuk1004).

Event Description

This report summarizes five malfunctions.A review of the reported information indicated that model ec500j vena cava filter allegedly experienced perforation.This information was received from various sources.The five malfunctions each involved a patient with no known impact to the patient.Of the five malfunctions, two were female (b)(6) and (b)(6) years old, one weighing (b)(6) lb.The remaining patients¿ age, weight, and gender were not provided.

Event Description

This report summarizes five malfunctions.A review of the reported information indicated that model ec500j vena cava filter allegedly experienced perforation.This information was received from various sources.The five malfunctions each involved a patient with no known impact to the patient.Of the five malfunctions, two were female 53 and 64 years old, one weighing 198 lb.The remaining patients¿ age, weight, and gender were not provided.

Manufacturer Narrative

H10: each of the five malfunctions had a lot numbers provided, and lot history reviews were performed.Two malfunctions had medical records provided; one investigation confirmed perforation and the other remained inconclusive.The remaining malfunctions did not have devices returned for evaluation; therefore, two investigations are inconclusive for perforation, and one investigation is inconclusive for perforation and detachment (2907), as no objective evidence has been provided to confirm any alleged deficiency with the devices.Based upon the available information, the definitive root cause is unknown.The devices are labeled for single use.H10: d4 (lot number: gfua4320, gfuk1004, udi no: n/a), g4.H11: h6 (device codes: 2993 - adverse event without identified device or use problem).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.

Manufacturer Narrative

H10: each of the five malfunctions had a lot number, and lot history reviews were performed.Three malfunctions had medical records and one of which included images.Two investigations confirmed perforation.For one malfunction, 2907- detachment was coded additionally and the investigation is inconclusive for the alleged perforation of the ivc and filter limb detachment.The remaining two malfunctions are inconclusive for perforation.Based upon the available information, the definitive root cause is unknown.The devices are labeled for single use.H10: d4(lot number: gfua4320, gfuk1004), g4 h11: b5, g1, h6(device) 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 five malfunctions.A review of the reported information indicated that model ec500j vena cava filter allegedly experienced perforation.This information was received from various sources.The five malfunctions each involved a patient with no known impact to the patient.Of the five malfunctions, two female patients ages ranged from 53 - 64 years, one of the two patients weighing 198 pounds.Third male patient was 36 year old.The remaining patients¿ age, weight, and gender were not provided.

Event Description

This report summarizes five malfunctions.A review of the reported information indicated that model ec500j vena cava filter allegedly experienced perforation.This information was received from various sources.The five malfunctions each involved a patient with no known impact to the patient.Of the five malfunctions, four female patients ages ranged from 37 - 65 years, one male patient is 36 years.Out of 5 patients, one patient weight was reported as 198 pounds; however; remaining patient's weight were not provided.

Manufacturer Narrative

H10: the lot number for all the five reported malfunction were provided, therefore, a lot history review were performed.The device was not returned for evaluation, however medical records were provided for all the five malfunctions of which three included images for review.Two malfunctions confirmed for the alleged perforation.Perforation is inconclusive for one malfunction.Out of 5 reported malfunctions, the investigation for one malfunction is confirmed for the alleged perforation, migration and detachment, therefore a0501 and a010402 trending codes were added.The remaining malfunction is identified for the reported tilt, detachment and perforation based upon medical record review and additionally a150202 code was added to the malfunction.Based upon the available information, the definitive root cause is unknown.The devices were labeled for single use.H10: d4(corporate lot number: gfua4320, gfuk1004).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: ECLIPSE FILTER
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9216189
• MDR Text Key: 163126596
• Report Number: 2020394-2019-04205
• 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,Followup
• Report Date: 10/08/2021

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: EC500J
• Device Lot Number: GFVI3402, GFWH2304, GFUE4470
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/21/2019
• Supplement Dates Manufacturer Received: 03/31/2020; 12/31/2020; 09/30/2021
• Supplement Dates FDA Received: 04/06/2020; 01/21/2021; 10/08/2021
• Patient Sequence Number: 1