MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - FEMORAL; VENA CAVA FILTER

Catalog Number RF310F

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/15/2010

Event Type  malfunction  

Manufacturer Narrative

No medical images have been made available to the manufacturer.As the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Medical records received and reviewed.Patient was diagnosed with multiple fibroids and an ovarian complex cyst.During a follow-up visit bilateral leg swelling was identified, ultrasound and ct scan of the abdomen was performed that demonstrated bilateral dvt and multiple pulmonary emboli.Patient was admitted to hospital for pe treatment and ovarian surgery.The inferior vena cava filter was deployed as the patient could not be on anticoagulation therapy.Approximately seven months post ivc filter placement a scheduled filter retrieval attempt was made.Despite multiple attempts made to retrieve the tilted filter, it remains implanted.The patient was reported to be hemodynamically stable at the conclusion of the procedure.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 approximately seven months post vena cava filter deployment, an attempt was made to retrieve the filter.Guided fluoroscopy demonstrated the filter apex against the ivc wall.Despite multiple devices used to capture and retrieve the filter unsuccessfully, the filter remains implanted.The patient was reported to be hemodynamically stable at the conclusion of the procedure.

Manufacturer Narrative

A further clinical review of the event details has been completed and identified a change in the mdr reportability.This event is reportable as a malfunction mdr.While failure to retrieve the tilted filter from the ivc may require procedural improvisation by medical professional, there was no patient injury or adverse patient outcome.Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.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.Image/photo review: as medical images were not provided, a review could not be performed.Conclusion: the medical records allege the filter was tilted against the right lateral wall and could not be retrieved.Based on the medical records, the investigation is confirmed for filter tilt and an unsuccessful retrieval attempt.The filter likely could not be retrieved because the filter was tilted against the ivc wall.The patient had several open surgical procedures after the filter was implanted.It is possible that the surgical procedures caused the filter to tilt within the ivc.However, the definitive root cause for the event is unknown.Labeling review: the current ifu (instructions for use) states: - warnings: movement, migration or tilt of the filter are known complications of vena cava filters.- precautions: procedures or activities that lead to changes in intra-abdominal pressure could affect the integrity or stability of the filter.- potential complications: procedures requiring percutaneous interventional techniques should not be attempted by physicians unfamiliar with the possible complications.Complications may occur at any time during or after the procedure.- possible complications include, but are not limited to, the following: filter tilt.Filter malposition.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.

• Brand Name: G2 FILTER SYSTEM - FEMORAL
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5294645
• MDR Text Key: 33427910
• Report Number: 2020394-2015-01999
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062887
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF310F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 80