MAUDE Adverse Event Report: CORDIS CASHEL 466P306X; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 466P306X

Device Problems Fracture (1260); Unintended Movement (3026)

Patient Problem Not Applicable (3189)

Event Date 07/05/2018

Event Type  Injury  

Manufacturer Narrative

Event date is unknown.Implant date is unknown.As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury, damage to patient, including, but not limited to: pain and suffering due to fractured filter with strut embedded near heart.The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.The inferior vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the vena cava for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated.The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart.Due to the nature of the complaint, the reported pain and suffering experienced by the patient could not be confirmed and the exact cause could not be determined.Without procedural films available for review, the reported ¿filter- fractured-separated - in patient¿ and ¿filter- migration¿ could not be confirmed and the exact cause could not be determined.The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.Inferior vena cava (ivc) filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the instruction for use (ifu) as such.Possible causes for filter migration includes mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters.Giving the limited information available at this time, clinical factor contributing to the migration could not be determined.Also, with the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design and/or manufacturing process of the device; therefore no corrective action will be taken.Should additional information become available, the file will be updated accordingly.

Event Description

As reported by the legal brief, the patient underwent placement of a trapease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury, damage to patient, including, but not limited to: pain and suffering due to fractured filter with strut embedded near heart.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 7714476
• MDR Text Key: 114853462
• Report Number: 1016427-2018-01673
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2018
• Initial Date FDA Received: 07/24/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening