MAUDE Adverse Event Report: CORDIS CORPORATION TRAPEASE PERMANENT VENA CAVA FILTER 55CM; THROMBECTOMY SYSTEMS (DQO)

Catalog Number 466P306AU

Device Problem Fracture (1260)

Patient Problems Pulmonary Embolism (1498); Cardiopulmonary Arrest (1765); Death (1802); Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 09/19/2014

Event Type  Injury  

Manufacturer Narrative

The product is not available for evaluation and testing.Additional information will be submitted within 30 days upon receipt.

Event Description

As reported through the legal department, a trapease permanent inferior vena cava (ivc) filter was placed through patient's right groin during the index procedure.The patient would present approximately fifty eight months after the index procedure to the emergency room (er) at another hospital complaining of back pain.She was evaluated by the er physician and had a computerized tomography (ct) scan of her abdomen and pelvis performed.The patient was noted to have a left retroperitoneal hematoma and a right pulmonary embolus which was due to fracturing/embolization of her trapease ivc filter and the perforation of the fractured filter through the wall of the inferior vena cava causing a retroperitoneal bleed.Unfortunately, it appears from the records that the radiologist that was reading the ct scans that evening missed the diagnosis of the embolus and the retroperitoneal bleed.The patient was sent home and the next morning had a cardiopulmonary arrest secondary to an expanding retroperitoneal hemorrhage.She was resuscitated by the paramedics at home, but coded again and subsequently died later that morning.A review of the ct scans by a second radiologist noted the presence of a retroperitoneal hematoma and a pulmonary embolus.

Manufacturer Narrative

Conclusion updated: as reported, a trapease permanent inferior vena cava (ivc) filter was placed through the patient's right groin during the index procedure.The patient presented approximately fifty eight months after the index procedure to the emergency room (er) at another hospital complaining of back pain.She was evaluated by the er physician and had a computerized tomography (ct) scan of her abdomen and pelvis performed.The patient was noted to have a left retroperitoneal hematoma and a right pulmonary embolus which the patient¿s medical records suggested was due to fracturing/embolization of her trapease ivc filter and the perforation of the fractured filter through the wall of the inferior vena cava causing a retroperitoneal bleed.As reported, it appears from the records that the radiologist that was reading the ct scans that evening missed the diagnosis of the embolus and the retroperitoneal bleed.The patient was sent home and the next morning had a cardiopulmonary arrest secondary to an expanding retroperitoneal hemorrhage.She was resuscitated by the paramedics at home, but coded again and subsequently died later that morning.A review of the ct scans by a second radiologist noted the presence of a retroperitoneal hematoma and a pulmonary embolus.Review of lot 14147556 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.No units were rejected during the final assembly of this lot.No other issues were noted that were considered potentially related to the reported complaint.No nonconformance records were issued for this lot.No excursions were found for lot 14147556.The reported filter fracture could not be confirmed as the device remained in the patient and was not returned for analysis, nor were procedural films provided.Ivc filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the ifu as such.Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to the fracture and migration of ivc filters.Based on the information provided in the dhr, there is no suggestion of a design or manufacturing related cause for the event experienced by the patient; therefore, no corrective action will be taken at this time.Inferior vena cava filters are used to prevent pe in patients with contraindications to, complications of, or failure of anticoagulation therapy and patients with extensive free-floating thrombi or residual thrombi following massive pe.Current evidence indicates that ivc filters are largely effective; breakthrough pe occurs in only 0% to 6.2% of cases.Contraindications to implantation of ivc filters include lack of venous access, caval occlusion, uncorrectable coagulopathy, and sepsis.Complications include misplacement or embolization of the filter, vascular injury or thrombosis, pneumothorax, and air emboli.Recurrent pe, ivc thrombosis, filter migration, filter fracture, or penetration of the caval wall sometimes occur with long-term use.Retroperitoneal hemorrhage is a well-documented, but infrequent, potential complication of ivc filter placement.Caval perforation leading to retroperitoneal hemorrhage occurs most commonly during the implantation rather than afterward (secondary to barb perforation etc.).Stiff guidewires, aggressive guidewire advancement, advancement of dilator and sheath without wire, movement of partially apposed filter are all potential causes of caval perforation/rupture.Back pain may be associated with such conditions.Vessel damage is an adverse event associated with all ivc filter implants and is listed in the ifu.Clinical study data and a review of published literature supports the safety and performance of vena cava filters when used as intended.Factors contributing to vessel damaged include patient, procedural, pharmacological and lesion.The patient also experienced cardiopulmonary arrest, a sudden stop in effective blood circulation due to the failure of the heart to contract effectively or at all.In this case, it was reported that the patient presented to the emergency room and ongoing bleeding may not have been diagnosed.Continued bleeding into the peritoneum, combined with a pulmonary embolism, may have led to a decrease in circulation and oxygenation ultimately resulting in cardiopulmonary arrest.

• Brand Name: TRAPEASE PERMANENT VENA CAVA FILTER 55CM
• Type of Device: THROMBECTOMY SYSTEMS (DQO)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 5183209
• MDR Text Key: 29645707
• Report Number: 9616099-2015-00514
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/05/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2012
• Device Catalogue Number: 466P306AU
• Device Lot Number: 14147556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 88