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

Catalog Number EC500F

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problems Pain (1994); Implant Pain (4561)

Event Date 04/19/2011

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review will not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.

Event Description

It was reported through the litigation process, approximately six months post filter deployment, attempts were made to retrieve the filter but were unsuccessful.Approximately eight years ten months post filter deployment, ct scan demonstrated the filter tilted, migrated and struts perforated the vena cava wall.Approximately eight years eleven months post filter deployment, the device was removed via an open laparotomy.The patient experienced pain at the deployment site.The current status of the patient was not provided.

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiry date: 07/2013), g2, g3, h6 (device).H11: section a through f ¿ the information provide by bd represents all 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 bd.

Event Description

It was reported through the litigation process, approximately six months post filter deployment, attempts were made to retrieve the filter but were unsuccessful.Approximately eight years ten months post filter deployment, ct scan demonstrated the filter tilted, migrated and struts perforated the vena cava wall.Approximately eight years eleven months post filter deployment, the device was removed via an open laparotomy.The patient experienced pain at the deployment site.The current status of the patient was not provided.

Event Description

It was reported through the litigation process, approximately six months post filter deployment, attempts were made to retrieve the filter but were unsuccessful.Approximately eight years and ten months post filter deployment, ct scan demonstrated the filter tilted, migrated and struts perforated the vena cava wall.Approximately eight years and eleven months post filter deployment, the device was removed via an open laparotomy.The patient experienced pain at the deployment site.The current status of the patient was not provided.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.After ten days, single view of abdomen was performed which showed an inferior vena cava filter was present at the l2 level.After six months, inferior vena cavogram and unsuccessful endovascular retrieval of vena cava filter was performed for high venous thromboembolic risk.The right internal jugular vein was accessed using the seldinger technique with ultrasound guidance.A 5-french sheath was inserted without difficulty.A 0.035-inch straight guidewire was advanced into the distal vena cava through the vena cava filter under direct fluoroscopic guidance.A contrast cavogram was performed both in anteroposterior and lateral projections.This demonstrated anterior tilt of the filter with what appeared to be an embedded tip anteriorly.With a kumpe catheter, attempted manipulation of the guidewire to the side of the tilt was unsuccessful.At this time, the right groin was prepped and draped, and another 5-french sheath was inserted.Again, using a kumpe catheter, were actually able to get to the side of the tilt of the wire; however, this was misled once the wire was straightened out.Attempted recovery of the filter with a recovery cone filter.This was hampered by the identification of the posterior leg of the filter being cephalad.It was unable to get to the tip of the filter.Then brought up a cone from the groin in a reverse fashion in an attempt to manipulate the filter from below and were actually able to get the cone into the neck of the filter and was able to slightly manipulate the filter but were unable to disengage the hook which was embedded toward the side of the caval wall.After multiple attempts to place a wire to the side of the tilt, the filter was finally aborted.The patient otherwise tolerated the procedure well.The sheath was removed.Pressure was being held at this time.A completion cavogram in a 60-degree oblique projection also demonstrates the tip embedded into the caval wall.After three years and nine months, four views of lumbar spine was performed which showed an inferior vena cava filter present at the l2 level with superior medial deviation of one of the legs.After four years and six months, computed tomography of abdomen and pelvis with intravenous contrast was performed which showed there was an inferior vena cava filter in situ.Multiple struts extend beyond the confines of the inferior vena cava wall into the retroperitoneum.A fragment of a strut resides along the anterior margin of the l3-l4 intervertebral disc space.After one month, the patient experienced intractable right upper quadrant abdominal and back pain, modified open extraction of inferior vena cava filter under fluoroscopy guidance and repair of the inferior vena cava and left renal vein was performed for malpositioned inferior vena cava filter with tilt and erosion of some of the prongs.Findings showed several of the prongs of the inferior vena cava filter were eroded through the right anterolateral wall of the inferior vena cava.There were several prongs that were in a retro aortic plane.There were also one prong inside of the left renal vein.There was also another prong in close proximity to the posterior wall of the second portion of the duodenum.There was another prong that was exteriorized and adherent to the posterior wall of the head of the pancreas.There was another portion of the prong that was inside of the anterior longitudinal ligament of the vertebra.All prongs were removed and confirmed via fluoroscopy.There were no remaining prongs in the inferior vena cava infrarenally.There were no prongs in the left renal vein.There were no prongs in the pericaval area.Procedure details: the right internal jugular vein was accessed.The head of the filter was eroded through the inferior vena cava wall.Several of the prongs were also eroded through the right anterolateral aspect of the wall of the inferior vena cava.Upon palpation, patient felt that there was a prong going into the left renal vein.The right renal vein was free of any prongs and were able to visualize several aortic prongs going into the retro aortic space.There was a single prong that was engraved into the anterior spinal longitudinal ligament.At this point, it was decided to use a wire cutter and cut several of the eroded prongs closer to the wall of the inferior vena cava.These prongs were then kept as a portion of the specimen.Once all the prongs were removed, proceeded to perform a purse string with a 5-0 prolene suture around the exteriorized head of the inferior vena cava filter.It was done again to obtain two purse strings devices around the head of the hook of the inferior vena cava filter.Then allowed the inferior vena cava filter to collapse inside of the 9-french short access sheath, and able to visualize the collapsing of the prongs under fluoroscopy guidance.Several of the prongs, including the one on the left renal artery and the one going into the retrocaval space, were detached from the main body of the inferior vena cava filter, which was now exteriorized out of the vena cava and inside of the 9-french short access sheath.The left renal inferior vena cava filter was then exteriorized by performing a small venotomy around the prong; and this venotomy; once the prong was exteriorized and removed, closed with 5-0 prolene suture.Later, proceeded to perform another purse string around the prong going into the retro aortic space.This prong was exteriorized outside of the inferior vena cava and outside of the retro aortic space.The purse string that was placed prior to removal of the prong was then tied down in the same fashion the two sutures that were priorly placed at the head of the inferior vena cava were tied down.There was no bleeding coming from this area once the filter was removed.Once this was completed, inferior vena cava was visualized under fluoroscopy, there was still a small area of metallic prong noted in the paravertebral ligaments.Proceeded to perform dissection around the anterior longitudinal ligament.The prong was able to be visualized underneath the anterior vertebral longitudinal ligament and proceeded to incise this ligament using a 10# blade.The remaining prong was able to be exteriorized and extracted passed off as a specimen completing the retrieval of all the different prongs associated with this bard eclipse filter.Confirmed removal of all the prongs and the inferior vena cava filter main body using fluoroscopy at the infrarenal and suprarenal inferior vena cava and also obtained images at the chambers of the heart and pulmonary arteries.There was no embolization of any portion of the prongs at this location.The patient was then awakened from anesthesia and sent to the recovery room in stable condition and extubated.After three months, the patient experienced chest and abdominal pain, computed tomography scan of abdomen and pelvis with intravenous contrast was performed which showed the caval filter present previously has been removed.Some of the struts are again visualized outside of the inferior vena cava.Therefore, the investigation is confirmed for the alleged filter tilt, perforation of the inferior vena cava, material deformation, filter limb detachment and retrieval difficulties.However, the investigation is inconclusive for the alleged filter migration.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 07/2013), g3, h6(method).H11: h6(result and conclusion).H11: section a through f - the information provided by bd 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 bd.H3 other text : device not returned.

• 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 12804
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10693717
• MDR Text Key: 211857083
• Report Number: 2020394-2020-20159
• 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: Other,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EC500F
• Device Lot Number: GFUF3051
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2022
• 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: BISACODYL, DOCUSATE, ENOXAPARIN, GABAPENTIN.; COLACE, TRAMADOL AND PRILOSEC.; ENOXAPARIN, GABAPENTIN, MIDODRINE.; MAGIC BULLET, COLACE, TRAMADOL AND PRILOSEC.; MIDODRINE, NITROFURANTOIN, POLYETHYLENE GLYCOL.; NITROFURANTOIN, POLYETHYLENE GLYCOL, MAGIC BULLET.; PERCOCET, BISACODYL, DOCUSATE.; TRAMADOL, NEURONTIN, PANTOPRAZOLE, PERCOCET.; TRAMADOL, NEURONTIN, PANTOPRAZOLE.
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White