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

Catalog Number MD800F

Device Problems Complete Blockage (1094); Occlusion Within Device (1423); Difficult to Remove (1528); Material Deformation (2976)

Patient Problems Occlusion (1984); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/29/2015

Event Type  malfunction  

Manufacturer Narrative

No device, no medical records or no medical images have been made available to the manufacturer. As the lot number for the device has not been provided, a review of the device history records could not be performed. The investigation of the reported event is currently underway.

Event Description

It was reported that approximately 18 months post vena cava filter deployment, during a scheduled filter retrieval, ivc occlusion was discovered at the level of the filter. No attempts were made to retrieve the filter. No other pertinent medical information was provided surrounding the events. Current patient status is unknown.

Manufacturer Narrative

Manufacturing review: a manufacturing review could not be conducted as the lot number was not provided. Visual/microscopic inspection: as the device was not returned, an inspection could not be performed. Functional/performance evaluation: as the device was not returned, an evaluation could not be performed. Medical records review: as medical records were not provided, a review could not be performed. Image/photo review: no medical images have been made available to the manufacturer. Conclusion: the investigation is inconclusive for an occluded ivc at the level of the filter. Based upon the available information, the definitive root cause for this event is unknown. Labeling review: the current ifu (instructions for use) states: warnings: note: it is possible that complications such as those described in the "warnings", "precautions," or "potential complications" sections of this instructions for use may affect the recoverability of the device and result in the clinician's decision to have the device remain permanently implanted. Potential complications: caval thrombosis/occlusion 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.

Manufacturer Narrative

Medical records review: the patient had a prophylactic inferior vena cava filter placed for prolonged immobility and intracranial hemorrhage. The right groin was prepped and draped in usual sterile fashion. The right common femoral vein was accessed and the filter was successfully deployed in an infrarenal location. The patient tolerated the procedure well without immediate complication. Conclusion: the device was not returned. Images were not received. Medical records were provided. The medical records allege a vena cava filter was implanted successfully in an infrarenal location via the right common femoral vein. No deficiencies were reported within the medical records. The investigation is inconclusive for the reported event. Based upon the available information, the definitive root cause for this event is unknown. (b)(4). 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

New information received - it was reported by the patient a vena cava filter was deployed in conjunction with a trauma situation/motor vehicle accident. After an unknown amount of time post filter deployment, an unsuccessful percutaneous filter retrieval attempt was performed. Based on medical records received from the patient, it was identified a vena cava filter was deployed successfully for dvt prophylaxis. The patient tolerated the procedure well. No additional information was received in the medical records provided.

• Brand Name: MERIDIAN FILTER SYSTEM - FEMORAL
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5478498
• MDR Text Key: 39854544
• Report Number: 2020394-2016-00237
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/27/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: MD800F
• Device Lot Number: GFXF3382
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial