|
Patient allegedly received an implant on (b)(6) 2010 via the right internal jugular vein due to post trauma.Patient reported an unsuccessful filter removal attempt on (b)(6) 2010 and a subsequently successful open filter retrieval on (b)(6) 2020.Patient is alleging device fracture, unable to retrieve, pain, open removal, failed removal and retained strut.Patient notes and further alleges experiencing: "pain in lower right abdominal.Scar tissue at vena cava.Pieces of filter broke off, one still at the spine of my back in muscle and another [sic] that could not be removed near arterial artery on the vena cava".Per the (b)(6) 2010 unsuccessful percutaneous filter retrieval: "impression : 1.Inferior vena cavagram demonstrates no evidence of caval thrombus.There is an inferior vena cava filter in place with some slight tilt to the right.Despite numerous attempts, the retrieval hook cannot be snared , consequently, the filter was left in place".Per the (b)(6) 2012 computed tomography (ct) abdomen with/without contrast: "impression: 1, interval rotation of an inferior vena cava filter with prongs traversing the caval wall.Non-enhancing soft tissue surrounding two of these prongs may reflect old thrombus.In one case, the soft tissue abuts duodenum, pancreas, and superior mesenteric vein and in particular is inseparable from the transverse duodenum.Although on sagittal imaging it does appear as though the prong does not enter into any of these structures, duodenal injury cannot be excluded.2.One prong traversing the caval wall has its tip mildly indenting the abdominal aorta, which may be a potential risk for aortic injury".Per the (b)(6) 2020 ct abdomen and pelvis with contrast: "findings: an inferior vena cava filter is in place.Tilting of the inferior vena cava (ivc) filter is noted with its superior tip posteriorly as wall as laterally to the right fairly similar in orientation when compared with the previous study dated 10-04-12.(at least) four of the ivc struts perforate the ivc wall with two directed to the left of midline with one ~approximating the anterior wall of the abdominal aorta with the other directed into the retroperitoneal fat.A third ivc strut projects through the anterolateral wall of the inferior vena cava anterolaterally on the right and is directed primarily anteriorly with its tip approximating a loop of content-filled bowel but not obviously entering such.A fourth ivc strut has seemingly perforated through the ivc wall posterolaterally on the right and is separate from the ivc filter proper lying within the retroperitoneal fat abutting the right psoas muscle anterolaterally.The ivc itself appears patent without evidence of thrombosis.No retroperitoneal pericaval soft tissue mass lesion is noted at the level of the ivc filter in place.No aneurysmal dilatation of the abdominal aorta is observed.The appearance of the (at least) four struts perforating the ivc wall at the level of the ivc filter has changed since the study dated 10-04·12".Per the (b)(6) 2020 open retrieval of ivc filter via laparotomy (successful): "findings: the celect filter was removed through a transverse incision in the right renal vein extending to the vena cava.Several prongs were identified extruding through the anterior, medial and posterior walls, but there was no evidence of aortic or bowel perforation.The infrarenal vena cava appeared chronically scarred but filled readily with blood once the clamps were removed.The filter device appeared to have been completely removed, with the main filter and a single fractured prong sent to pathology for examination".Per the (b)(6) 2020 ct abdomen pelvis without contrast: "impression: 1.Postoperative changes of ivc filter removal with expected volume of retroperitoneal fluid and edema as well as free intraperitoneal air.Retained limb is again the lateral aspect of the right psoas muscle at the level of the right kidney, unchanged from previous".Per the (b)(6) 2020 x-ray abdomen: "impression: single retained filter limb".
|
|
Investigation: the following allegations have been investigated: fx (retained fragments), vena cava perforation, difficult removal, migration, tilt, abdominal pain, scarred ivc.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.Filter fracture has been reported and may be either symptomatic or asymptomatic.Fracture of a filter leg may be due to repetitive motion on a filter leg in an unusual, stressed position, such as a filter leg penetrating/perforating the ivc; or a filter leg being caught in a side branch (e.G., a renal vein).Other potential causes of filter fracture may include excessive force or manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Retrieval of a fractured filter or filter fragments (including embolized fragments) using endovascular techniques has been reported.Potential adverse events that may occur include, but are not limited to, the following: filter fracture, filter or filter fragment embolization, trauma to adjacent structures.Filter interacts with ivc wall, e.G.Penetration/perforation/embedment.This may be either symptomatic or asymptomatic.Potential causes may include improper deployment; and (or) excessive force or manipulations near an in-situ filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Potential adverse events that may occur include, but are not limited to, the following: trauma to adjacent structures, vascular trauma, vena cava perforation, vena cava penetration.Physician practice guidelines and published guidance from regulatory agencies recommend that patients with indwelling filters undergo routine follow-up.The risks/benefits of filter retrieval should be considered for each patient during follow-up.Once protection from pe is no longer necessary, filter retrieval should be considered.Filter retrieval should be attempted when feasible and clinically indicated.Filter retrieval is a patient-specific, clinically complex decision; the decision to remove a filter should be based on each patient¿s individual risk/benefit profile (e.G., a patient¿s continued need for protection from pe compared to their experience with and (or) ongoing risk of experiencing filter-related complications).For all retrievable ivc filters, retrieval becomes more challenging with time, and this is commonly due to encapsulation of the filter legs or hook (in a tilted filter) by tissue ingrowth.The filter is designed to be retrieved with the günther tulip vena cava filter retrieval set.It may also be retrieved with the cloversnare® vascular retriever.Cook has not performed testing to evaluate the safety or effectiveness of filter retrieval using other retrieval systems or techniques.The published clinical literature includes descriptions of alternative techniques for filter retrieval; use of these techniques varies according to physician experience, patient anatomy, and filter position.The safety or effectiveness of these alternative retrieval techniques has not been established.Specific for ¿embedded¿ a filter that is embedded in the wall of the ivc may be difficult to retrieve.For all retrievable ivc filters, retrieval becomes more challenging with time, and this is commonly due to encapsulation of the filter legs or hook (in a tilted filter) by tissue ingrowth.Filter or filter fragment migration and (or) embolization (e.G., movement to the heart or lungs) has been reported.Filter or filter fragment movement has occurred in both the cranial and caudal direction and may be either symptomatic or asymptomatic.Potential causes may include filter placement in ivcs with diameters smaller or larger than those specified in these instructions for use; improper deployment; deployment into thrombus; dislodgement due to large thrombus burdens; and (or) excessive force or manipulations near an in situ filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Potential adverse events that may occur include, but are not limited to, the following: filter migration, trauma to adjacent structures.Filter tilt has been reported.Potential causes may include filter placement in ivcs with diameters larger than those specified in these instructions for use; improper deployment; manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter); and (or) a failed retrieval attempt.Excessive filter tilt may contribute to difficult or failed retrieval; vena cava wall penetration/perforation; and (or) result in loss of filter efficiency.Potential adverse events that may occur include, but are not limited to, the following: unacceptable filter tilt.Unknown if the reported abdominal pain, scarred ivc are directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 devices in lot.To date, there are no other complaints have been reported against the lot.The associated work order was reviewed.No related/relevant notes were documented.The device is manufactured and inspected according to specifications.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
|
