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

Catalog Number MD800J

Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682); Extrusion (2934)

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

Event Date 09/08/2017

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for tilt and perforation of the ivc as no objective evidence has been provided to confirm any alleged deficiency with the filter.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.The information provided by bard 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 bard.

Event Description

It was reported through the litigation process that approximately four years five months post filter deployment a ct scan demonstrated the ivc filter perforated and tilted.There were no reported attempts made to retrieve the filter.The current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: a device history record review could not be performed as the lot number is unknown.Investigation summary:the device was not returned for evaluation.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Post placement cavogram demonstrates good placement.Approximately four years and five months post filter deployment, inferior vena cava filter in place infra renal location which appears to be a bard g2 filter.This was somewhat tilted with slight leg extension beyond the inferior vena cava.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc).However, the investigation is inconclusive for alleged filter tilt.Based on the provided medical records, there is no clear evidence to confirm for filter tilt as it reported that, ¿this was somewhat tilted with slight leg extension beyond the inferior vena cava."based upon the available information, the definitive root cause is unknown.Labeling review:a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.H10: b5,b6,g2,g3.H11: d1,d4(product catalog number),h6(device, method and 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.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism.Approximately four years and five months post filter deployment, a computed tomography scan showed that the filter tilted and struts perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.The current status of the patient is unknown.

• Brand Name: MERIDIAN FILTER SYSTEM - JUGULAR
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7655277
• MDR Text Key: 113002476
• Report Number: 2020394-2018-01042
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K102511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MD800J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLONIDINE, DIDRONEL600, PROSCAR; COUMADIN, LASIX, ELAVIL, NORVASC, COREG; DILAUDID, REGLAN, BACLOFEN, AMLODIPINE, CARVEDILOL; FIORICET, HYDROCHLOROTHIAZIDE, ULTRAM; NEURONTIN, HYDRALAZINE, FLOMAX, TRAZODONE; ONDANSETRON, NALOXONE, SENNA, DIPHENHYDRAMINE; TERAZOSIN, DEXAMETHASONE, ACETAMINOPHEN; VALIUM, LABETALOL, ALDACTONE, PROCARDIA
• Patient Age: 49 YR
• Patient Weight: 109