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Description of event according to initial reporter: partially successful retrieval of a tulip placed 6/7 years ago.One primary strut had fractured and penetrated the aorta.A separate piece of secondary strut was seen just to the right of that.The main body was still intact, however, the hook was embedded in the caval wall and a primary strut attached to the filter's main body had penetrated the duodenum causing the patient abdominal pain.We were able to separate the filter hook from the wall using the loop snare technique then with the 9fr sheath from the gtrs set for added support inside the 16fr x 45 performer sheath used with blunt force to get the legs off the wall and cover the filter for successful retrieval.Due to caval spasm and significant fibrin covering the fractured leg, we were unable to retrieve it, but doc may bring patient back for another attempt once the cava returns to normal.Successful case due to the fact we were able to retrieve the main body of the filter and relieve the patient's abdominal pain.Patient outcome: there is an unintended section of the device remained inside the patient¿s body.The perforated duodenum caused the patient abdominal pain.
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Manufacturer ref# (b)(4) summary of investigational findings: partially successful retrieval of a tulip filter placed 6-7 years ago.One primary filter leg had fractured and perforated the aorta and a separate piece of a secondary strut was seen to the right of that.The main body of the filter was intact, but the hook was embedded in the caval wall and a primary strut attached to the body had penetrated the duodenum causing abdominal pain to the patient.The hook was separated from the wall and the filter was covered for successful retrieval, but the fractured primary leg was not retrieved due to caval spasm and significant fibrin covering it.However, the patient¿s abdominal pain was resolved with removal of the filter and the patient may be brought back for another attempt of removing the fractured leg.There are adequate controls in place to ensure that this type of device is manufactured to specifications.Two photographs from a retrieved tulip ivc filter demonstrate a glidewire in a loop snare configuration through the neck of the ivc filter.There are only 3 primary filter legs present and one of the primary filter legs present lacks the associated secondary filter arms in the typical configuration.A set of the secondary filter arms are fractured within the midportion of the filter arm, and no longer wrapped around a primary filter leg.These fractured secondary filter arms are likely the arms corresponding to the primary filter leg lacking arms.The primary filter leg completely absent also appears to lack the secondary filter arms associated with that leg.The donor site of the absent primary filter leg is seen at the filter neck.The donor site for the secondary arms are not appreciated.There is minimal clot/fibrin material associated with the filter neck.A single dsa image following ivc filter retrieval demonstrates a primary filter leg still remaining and the patient's body with what appears to be a set of secondary filter arms located just cranial to this primary filter leg.Given the single subtracted view, the exact location of these remaining filter fragments is not possible to determine on this image.There is a 16-french sheath positioned in the ivc above the level of the filter fragments and there appears to be a catheter positioned in the aorta as well.The filter fragments are not near the catheter in the aorta.The complaint report describes the presence of multiple grade 3 interactions involving the primary filter legs extending into the duodenum, as well as penetrating the aorta.Unfortunately, on the images submitted for review, these findings cannot be confirmed or refuted.The only image of the patient submitted for review is a digitally subtracted angiogram without any contrast following retrieval of the fractured filter, so its configuration prior to retrieval is not seen or evaluated on the images submitted.The complaint report describes a primary filter leg fracture with penetration of the aorta.However, on the dsa image, the remaining primary filter leg fragment does not project adjacent to the catheter in the aorta, so penetration of the aorta is not felt to be very likely in this configuration, but cannot be completely excluded.The complaint report also discusses "piece of secondary strut ", which is present on the image located just cranial to the primary filter fracture remaining.Unfortunately, without more imaging to review, including the initial placement images, it is impossible to determine if there is a leading cause for the development of potential migration, and extensive penetrations resulting in filter fracture, as detailed above.In the absence of cross-sectional imaging to evaluate the relative position of the ivc filter relative to the adjacent structures and potential interactions that may have contributed to abnormal forces, it is only speculation as to why these fractures occurred.Importantly, the report describes patient experiencing abdominal pain due to the reported duodenal perforation.This perforation was resolved with retrieval of the ivc filter and the patient¿s abdominal pain was relieved.The tulip filter was returned and evaluation found that one primary filter leg and four secondary filter legs had fractured and were not returned.A detailed scanning electron microscopy (sem) analysis of the filter revealed a minor inclusion in the fracture surface of the primary leg, but did not reveal any material defects and the inclusion was not the reason for the fracture itself, but may have influenced on the area of the fracture.Per the product evaluation the fractured filter legs are likely due to stress/metal fatigue.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.It is noted that the filter was placed 6-7 years ago, but according to current instructions for use it is stated under optional filter retrieval that filter retrieval should be considered, once protection from pe is not longer necessary.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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