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

Model Number 466P306X

Device Problem Occlusion Within Device (1423)

Patient Problem Thrombosis (2100)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

As reported in article wang et al: long-term complications of inferior vena cava filters, j vasc surg venous lymphat disord (2016) 5 (1):33-41 there were: six (6) events of filter fracture; five (5) events of filter thrombosis-two (2) complete and three (3) partial; two (2) events of inferior vena cava (ivc) perforation; and two (2) events of ivc perforation with retroperitoneal bleeding for the trapease arm of the study.There were six (6) events of filter fracture; two (2) events of ivc perforation; and two (2) events of ivc perforation with retroperitoneal bleeding for the optease arm of the study.The article noted that some inferior vena cava filter (ivcf) complications only manifest after prolonged dwell time (ivcf fracture, inferior vena cava [ivc] occlusion, and ivc perforation).The aim of this study was to assess the incidence of long-term complications of ivcfs using ideal imaging, contrast-enhanced computed tomography (ct).From 2007 to 2009, 3,303 ivcfs were placed across a large healthcare region.Only patients with contrast enhanced cts of the abdomen at a minimum of four (4) years post-ivcf implantation were selected.A retrospective observational study was performed in ninety-six (96) patients.Primary outcomes were prevalence and predictive factors for ivcf fracture, ivc thrombosis, and ivc perforation.If a filter fracture was detected by ct, all prior cts, as well as plain films of the abdomen or lumbar spine were reviewed to determine the first observation of fracture.All fractures were characterized by the number of struts fractured and any fracture embolization or migration was noted.Cava thrombus was recorded as either partial cava thrombosis (defined as filling defect in the ivc and either separate from the filter or extending beyond the filter) or complete cava thrombosis (defined as no filling of the ivc 6 chronic findings including retraction of the ivc or iliac vein[s]).If cava thrombus was detected by ct, all prior cts were reviewed to determine the first observation of cava thrombus.Ivc perforation was defined as a filter leg extending greater than three (3) mm.Beyond the ivc wall.The number of perforating struts and maximum amount of perforation was recorded for each ct.If there was direct extension to or within a retroperitoneal structure, the structure was recorded.If ivc perforation was detected by ct, all prior cts were reviewed to determine the first occurrence of perforation.The previously noted malfunctions and adverse events were reported for the optease and/or trapease vena cava filters.  due to the nature of the complaint and the type of product, there were no products returned for analysis.  additionally, as the sterile lot number was not available, device history record review could not be performed.  the optease and trapease vena cava filters are 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.Thrombosis does not represent a device malfunction.  without procedural films for review, the reported filter fracture 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.  perforation of the vena cava was also reported but could not be confirmed without procedural/follow up films for review.The instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.  given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design and manufacturing process of the device; therefore no corrective action will be taken.Please note that this is the initial/final report for this product/file.  this is one of seven reports for this literature article: (b)(4).

Event Description

During a literature search an article was found: wang et al: long-term complications of inferior vena cava filters, j vasc surg venous lymphat disord (2016) 5 (1):33-41.As noted in the publication, there were: six (6) events of filter fracture; five (5) events of filter thrombosis-two (2) complete and three (3) partial; two (2) events of inferior vena cava (ivc) perforation; and two (2) events of ivc perforation with retroperitoneal bleeding for the trapease arm of the study.There were six (6) events of filter fracture; two (2) events of ivc perforation; and two (2) events of ivc perforation with retroperitoneal bleeding for the optease arm of the study.The objective of the abstract was that some inferior vena cava filter (ivcf) complications only manifest after prolonged dwell time (ivcf fracture, inferior vena cava [ivc] occlusion, and ivc perforation).The incidence of these complications is often based on mathematical projections given the lack of long-term imaging follow-up.The aim of this study was to assess the incidence of long-term complications of ivcfs using ideal imaging, contrast-enhanced computed tomography (ct).Methods: from 2007 to 2009, (b)(4) ivcfs were placed across a large healthcare region.Only patients with contrast enhanced cts of the abdomen at a minimum of four (4) years post-ivcf implantation were selected.A retrospective observational study was performed in ninety-six (96) patients.Primary outcomes were prevalence and predictive factors for ivcf fracture, ivc thrombosis, and ivc perforation.If a filter fracture was detected by ct, all prior cts, as well as plain films of the abdomen or lumbar spine were reviewed to determine the first observation of fracture.All fractures were characterized by the number of struts fractured and any fracture embolization or migration was noted.Cava thrombus was recorded as either partial cava thrombosis (defined as filling defect in the ivc and either separate from the filter or extending beyond the filter) or complete cava thrombosis (defined as no filling of the ivc 6 chronic findings including retraction of the ivc or iliac vein[s]).If cava thrombus was detected by ct, all prior cts were reviewed to determine the first observation of cava thrombus.Ivc perforation was defined as a filter leg extending greater than three (3) mm.Beyond the ivc wall.The number of perforating struts and maximum amount of perforation was recorded for each ct.If there was direct extension to or within a retroperitoneal structure, the structure was recorded.If ivc perforation was detected by ct, all prior cts were reviewed to determine the first occurrence of perforation.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; p.o. box 025700; miami FL 33152
• Manufacturer (Section G): CORDIS CORPORATION; p.o. box 025700; miami FL 33152
• Manufacturer Contact: cecil navajas ; 14201 nw 60th ave.; miami lakes, FL 33014
• MDR Report Key: 6398425
• MDR Text Key: 69733903
• Report Number: 1016427-2017-00222
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/17/2017
• Date Manufacturer Received: 02/17/2017
• 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): Life Threatening