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

Catalog Number MD800F

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only event reported to date for this lot number and failure mode.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: the patient with history of pulmonary emboli was admitted to the hospital with large retroperitoneal hematoma and was scheduled for vena cava filter placement.The neck was prepped and draped and ultrasound was used and identified a side branch; however successful cannulation of the innominate vein could not be performed.The groin was prepped and draped and ultrasound was used and the common femoral vein was accessed.A sheath was advanced to the terminal inferior vena cava and a venacavogram was performed which demonstrated no evidence of caval clot or duplicate anatomy.The dilator was removed and the filter was deployed without incident.The sheath was removed and pressure was held.There were no immediate complications.The patient was discharged approximately nine days post admission with resolving retroperitoneal hematoma.Approximately two years seven months post filter deployment, the patient had angioplasty performed and the vena cava filter removed.Access was gained to the right groin and a venogram demonstrated a completely occluded common iliac vein with a large network of collaterals.The right brachial arm was accessed and a venogram was performed which demonstrated a stenotic axillary vein, occluded subclavian and innominate vein, and stenotic superior vena cava.The veins were serially dilated and a 12 french sheath was advanced into the svc.Using a 7 french multipurpose catheter and a 20 mm loop snare, the filter was snared and removed.Once the filter was removed, the common iliac artery occlusion was crossed; however, the ivc lesion was unable to be crossed.The wire from the brachial vein was brought all the way down to the left side through the occluded ivc and down to the left common femoral vein.The wire was then tightened down in the iliac bifurcation and brought the double looped wire out the right groin.The ivc and common iliac vein were then serially dilated with angioplasty balloons.Completion venogram and completion ivus demonstrated a completely patent iliac system and ivc.The wire and sheaths were removed and pressure was held to obtain hemostasis.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: the device was not returned for evaluation and images were not provided for review.Medical records were provided and reviewed.Approximately two years and seven months post filter deployment, the patient had angioplasty performed and the vena cava filter removed.A venogram demonstrated a completely occluded common iliac vein with a large network of collaterals.The veins were serially dilated and a 12 french sheath was advanced into the svc.Using a 7 french multipurpose catheter and a 20 mm loop snare, the filter was snared and removed.Based on the provided medical records, the investigation is inconclusive for the alleged occlusion of the filter as no objective evidence has been provided to confirm any alleged deficiency with the filter.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: potential complications: - caval thrombosis/occlusion 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.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 that a vena cava filter was deployed successfully, the reason for the filter deployment was not provided.No alleged deficiency with the device was reported.No other information regarding this event was received.Patient status was not provided.New information received: it was reported a vena cava filter was deployed in a patient diagnosed with deep vein thrombosis/pulmonary embolism.After an unknown amount of time post filter deployment, the filter was allegedly occluded.The filter was successfully removed percutaneously.Based on a review of medical records received, the patient with history of pulmonary emboli was admitted to the hospital with large retroperitoneal hematoma and had a vena cava filter deployed without incident.Approximately two years seven months post filter deployment, the patient was scheduled for filter retrieval.The right groin and right brachial vein were accessed and the filter was successfully snared and removed.Upon removal of the filter, serial dilation was performed with angioplasty balloons.Completion venogram and ivus demonstrated a completely patent iliac system and ivc.Manual pressure was held and hemostasis was achieved.No additional information was provided in the medical records received.

• 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 ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6613297
• MDR Text Key: 76764023
• Report Number: 2020394-2017-00565
• 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
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2013
• Device Catalogue Number: MD800F
• Device Lot Number: GFWF3264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1