MAUDE Adverse Event Report: CORDIS CASHEL FEMORAL 55CM KIT; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466F230AF

Device Problems Fracture (1260); Difficult to Remove (1528); Retraction Problem (1536); Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2017

Event Type  Injury  

Manufacturer Narrative

The product was not returned for analysis.Manufacturing record (dhr) review was conducted and the product met quality requirements for product acceptance per the applicable manufacturing quality plan.Additional information will be submitted within 30 days upon receipt.

Event Description

The report received indicated that the physician implanted a 55 cm.Femoral optease inferior vena cava (ivc) filter via the femoral approach.Upon viewing the angiogram, the ivc filter was placed well below both rentals and seemed well opposed to the ivc walls and not damaged.Thirteen (13) days after the filter implantation, the physician attempted to retrieve the filter but was not successful.The physician was never able to hook the filter with the snare.After reviewing the angiogram, the filter appeared to be tilted forward, elongated, and possibly fractured.The filter remains implanted.The patient is very large in size.Additional information received indicated that there were no reported product issues noted with the filter prior to the attempted retrieval.The reported product issues of: possible filter fracture, tilt, and elongation were noted after the attempted retrieval attempt.No additional information (such as contributing factors etc.) were available regarding the attempted filter retrieval.Regarding the implantation of the filter: the indication for filter insertion was deep vein thrombosis (dvt).The dvt was documented/diagnosed by a duplex venous doppler study of the lower extremities.The patient has a history of dvt and coumadin usage.There was no thrombus present at the delivery site.The ivc was reported to be of normal size and shape.No measurement of the ivc was done, visualization of the ivc was done via angiography.There were there no reported peri-procedural or post-procedural complications.There were no reported delivery problems.The filter was not ever in an acute or sharp bend in the delivery tube while it was out of the storage tube.The filter was placed in the ivc below/under the renal arteries.There was no associated filter migration.No additional information is available.

Manufacturer Narrative

The physician implanted an optease inferior vena cava (ivc) filter via the femoral approach.Upon viewing the angiogram, it was noted that the ivc filter was placed well below both renal veins and appeared well opposed to the wall of the ivc and not damaged.There were no reported peri-procedural or post-procedural complications.Thirteen (13) days after the filter implantation, the physician attempted to retrieve the filter but was not successful.The physician was never able to hook the filter with the snare.After reviewing the angiogram, the filter appeared to be tilted forward, elongated, and possibly fractured.The filter remains implanted.Per the report received it was stated that the patient¿s size was significant.Additional information received indicated that there were no reported product issues noted with the filter prior to the attempted retrieval.The reported product issues of: possible filter fracture, tilt, and elongation were noted after the attempted retrieval attempt.The indication for filter insertion was deep vein thrombosis (dvt).The ivc was reported to be of normal size and shape.No measurement of the ivc was done, visualization of the ivc was done via angiography.There were no reported delivery problems.The filter was not ever in an acute or sharp bend in the delivery tube while it was out of the storage tube.No additional information is available.The product was not returned for analysis.Four angiographic still images were received of an inferior vena cava filter.Filter appears possibly tilted however the degree of tilt is indeterminable.A device history record (dhr) review of lot 17456734 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The optease 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.With the procedural films for that are available for review, the degree of the possible filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.The legal brief also noted that the filter was possibly fractured.Upon review of the available films, a fracture is indeterminable.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.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.Should additional information become available, the file will be updated accordingly.

• Brand Name: FEMORAL 55CM KIT
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• 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
• MDR Report Key: 6967884
• MDR Text Key: 89919722
• Report Number: 9616099-2017-01521
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 466F230AF
• Device Lot Number: 17456734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/27/2017
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2016
• 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; Required Intervention