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

Catalog Number EC500F

Device Problem Extrusion (2934)

Patient Problem Great Vessel Perforation (2152)

Event Date 08/26/2011

Event Type  No Answer Provided  

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: the patient with a history of recurrent deep venous thrombosis (dvt), factor v leiden deficiency and pulmonary embolism was diagnosed with new onset of recurrent left lower extremity dvt despite a therapeutic anticoagulation level.Ct was performed to determine the level of the renal vein for ivc filter insertion.The right renal vein was identified to enter the cava at the level of the upper body of l1.The left renal vein was slightly lower in the mid to lower body of l1.The following day, the patient¿s right groin was prepped and draped.Using direct ultrasound guidance, the right common femoral vein was punctured with a micropuncture needle.The ivc filter delivery system was advanced and the filter was deployed with the tip in the region of the lower body of l1.A spot film was obtained confirming successful infrarenal placement.The delivery system was removed and hemostasis was achieved.Approximately two months post filter deployment, ct performed for posterior abdominal pain and evaluation for renal calculi identified the filter to be in place but with two posterior limbs extending beyond the caval wall.The report recommended reassessment of the filter.The patient was discharged the following day with a clinical diagnosis of renal colic.Approximately five months post filter deployment, a follow-up ct performed confirmed the ivc filter to be in place with no change compared to the previous study.Multiple subsequent ct exams over the next four years identified the filter to remain stable and unchanged in position.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: the device was not returned.Images were not provided.Medical records were provided and reviewed.A vena filter was successfully deployed.Approximately two months post filter deployment, a ct identified the filter to be in place with two posterior limbs extending beyond the caval wall.Based on the provided medical records, the investigation can be confirmed for perforation of the ivc wall by filter limbs.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: potential complications: perforation or other acute or chronic damage of the ivc wall.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 provided.The patient status at this time is unknown.New information received: medical records were received and reviewed.Approximately two months post vena cava filter deployment for dvt despite therapeutic anticoagulation, an incidental finding on ct identified two filter limbs extending beyond the caval wall.All subsequent imaging noted the filter to be stable and unchanged in position.No additional information surrounding this event was provided in the medical records received.

• Brand Name: ECLIPSE 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: 6156819
• MDR Text Key: 61856053
• Report Number: 2020394-2016-01149
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093659
• 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: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EC500F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: COUMADIN, OMEPRAZOLE
• Patient Age: 24 YR
• Patient Weight: 104