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

Catalog Number EC500F

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Extrusion (2934)

Patient Problems Pulmonary Embolism (1498); Thrombus (2101); Great Vessel Perforation (2152)

Event Date 07/30/2013

Event Type  Injury  

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.Medical records review: the patient at high risk for deep vein thrombosis with progressive pneumoperitoneum was scheduled for inferior vena cava (ivc) filter placement.The right femoral vein was accessed and a venogram was performed which demonstrated the renal vein takeoffs at l2-l3.An ivc filter was deployed at the l2-l3 interspace without complication.Following filter placement, the patient underwent an exploratory laparoscopy with subsequent percutaneous placement of a peritoneal dialysis catheter.Approximately eleven days post filter deployment, the patient underwent ventral hernia repair with mesh.Following surgery, the patient was diagnosed with heparin induced thrombocytopenia and was found to have multiple pulmonary embolism.Approximately fifteen days post filter deployment, ct scan of the abdomen demonstrated thrombus in the ivc extending above the filter into the renal veins.Approximately one year two months post filter deployment, the patient was scheduled for filter retrieval.Ct scan demonstrated a tilted filter.A snare device was unable to snare the filter.Long biopsy forceps were advanced to free the filter head from the ivc wall; however, it was difficult to come into close vicinity of the filter hook.The filter was unable to be retrieved and the decision was made to conclude the procedure.Investigation summary: the device was not returned for evaluation.Images were not provided for review.Medical records were provided and reviewed.Based on the medical records, the investigation can be confirmed for tilted filter and removal difficulties.It can also be confirmed that the patient experienced pe after filter implantation, and a clot above the filter.The origin of the pe and the relationship to the filter has not been established in the provided medical records.Additionally, the investigation is inconclusive for perforation of the ivc.Per the provided medical records, the patient had abdominal surgery.Per the instructions for use (ifu), "procedures or activities that lead to changes in intra-abdominal pressure could affect the integrity or stability of the filter." therefore, it is possible the surgery affected the stability or positioning of the filter.Per the provided medical records, the filter was also tilted.A tilted filter could lead to retrieval difficulties.However, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warnings/potential complications: acute or recurrent pulmonary embolism.This has been reported despite filter usage.It is not known if thrombi passed through the filter, or originated from superior or collateral vessels.Movement, migration or tilt of the filter are known complications of vena cava filters.Perforation or other acute or chronic damage of the ivc wall, filter tilt, filter malposition.Precautions: procedures or activities that lead to changes in intra-abdominal pressure could affect the integrity or stability of the filter.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 through the litigation process that at some time post filter deployment allegedly the filter tilted and perforated into organs.The device has not been removed after an attempted but unsuccessful percutaneous removal procedure.The status of the patient is unknown.

• 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: 7365647
• MDR Text Key: 103305697
• Report Number: 2020394-2018-00271
• 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: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2016
• Device Catalogue Number: EC500F
• Device Lot Number: GFXA3819
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2013
• 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: BENEFIBER, CINNAMON, FLEXERIL, FERROUS SULFATE; COUMADIN; LASIX, CEPHULAC, MAGNESIUM, MULTIVITAMIN, PROTONIX; POTASSIUM CHORIDE, XIFAXAN, SENOKOT, ALDACTONE
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 57 YR