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Per complaint form: dr.(b)(6) placed an evolution duodenal stent in a stricture in the duodenal bulb of the patient.Six week post, he went back in and found the metal stent somewhat collapsed and floating in the bulb.He said when placed it was 6cm, when he pulled it out it had collapsed to 1cm.He said it seemed like it might have been defective.The stent was removed from the body after it was found floating in the duodenal bulb six weeks post procedure.There was no patient issues, he just had to place another stent.Also, in same area he had also placed a wallmax stent, that stent had no issues and is still in the patient.
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Per complaint form: dr.(b)(6) placed an evolution duodenal stent in a stricture in the duodenal bulb of the patient.Six week post he went back in and found the metal stent somewhat collapsed and floating in the bulb.He said when placed it was 6cm, when he pulled it out it had collapsed to 1cm.He said it seemed like it might have been defective.The stent was removed from the body after it was found floating in the duodenal bulb six weeks post procedure.There was no patient issues, he just had to place another stent.Also, in same area he had also placed a wallmax stent, that stent had no issues and is still in the patient.
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Per complaint form: dr.(b)(6) placed an evolution duodenal stent in a stricture in the duodenal bulb of the patient.Six week post he went back in and found the metal stent somewhat collapsed and floating in the bulb.He said when placed it was 6cm, when he pulled it out it had collapsed to 1cm.He said it seemed like it might have been defective.The stent was removed from the body after it was found floating in the duodenal bulb six weeks post procedure.There was no patient issues, he just had to place another stent.Also, in same area he had also placed a wallmax stent, that stent had no issues and is still in the patient.Update [received via email on (b)(6)2018]: "after further discussion with doctor and his superior is was determined that this stent was deployed where the stricture ended and possibly where there was not enough stricture to hold the stent.However, there was concern about how the stent seemed to collapse on itself regardless.".
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510(k) number: k163468.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: (b)(4).Information pertaining to mfr site as follows: importer site contact and address: (b)(6).Cook medical incorporated (cmi) (b)(4).Importer site establishment registration number:(b)(4).Device evaluation: the evo-22-27-6-d device of unknown lot number was unavailable for evaluation.Additional information received: the following unanswered questions were sent to the dm vial email on (b)(6)2018.Ar (b)(6)2018: what is the reorder number of the wire guide used with this device? if not, with the device in question, how was the procedure finished? device was placed and in place for 6 weeks.The device was removed and replaced with another stent.What is the endoscope manufacturer and model number that was used during the procedure? olympus scope had dilation of the stricture been performed prior to stent placement? what was the diameter of the stricture at the time of stent placement (in mm)? what was the length of the stricture at the time of stent placement (in cm)? please describe the location in the body where the stent was to be placed.Was resistance encountered when advancing the wire guide through the stricture? was resistance encountered when advancing the introducer and stent into position? did any section of the device detach inside the patient? only then intended stent was placed in patient and issue was noted 6 weeks post placement was the stent partially deployed when removed from the patient? stent was placed in patient and issue was noted 6 weeks post placement after placement, was stent position verified? if yes, please describe how.After placement, was the endoscope advanced through the stent? please estimate amount of time the stent was in place prior to this occurrence.Did the patient undergo chemotherapy or radiation treatments after stent placement? issue was noted 6 weeks post placement did any unintended section of the device remain inside the patient¿s body? no if yes, please describe.Did the patient require any additional procedures due to this occurrence? yes if yes, please describe.Device was removed from patient did the product cause or contribute to the need for additional procedures? yes if yes, please specify additional procedures and provide details.Device was removed from patient has the complainant reported any adverse effects on the patient due to this occurrence? no has the complainant reported that the product caused or contributed to the adverse effects? no stent was in the patient for six weeks.The patient had the following pre-existing conditions: carcinoma in the duodenum there is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony and images that the customer sent to cook ireland.Image review: impression: as discussed in the complaint report, although no images were submitted, the evolution duodenal stent was placed for stricture related to primary carcinoma of the duodenum.The complaint report describes that 6 weeks after placement repeat endoscopy demonstrated the "metal stent somewhat collapsed and floating in the bulb".It is noted that when the stent was placed it was 6 cm and when it was removed it was 1 cm.These measurements appear to be in reference to the overall stent length and not the diameter of the stent.The ct and fluoroscopic images are presumably at or immediately after the time of initial intervention as the evolution duodenal stent appears appropriate in its size and configuration.The coronal ct scan images give the appearance of narrowing within the midportion of the stent, but this is felt to represent an artifact due to slice selection.The single endoscopic image demonstrates the evolution duodenal stent with a large amount of debris within the stent.The stent lattice is very compressed when compared to the previous fluoroscopic image.This suggests the stent has significantly foreshortened.Given the structure of the evolution duodenal stent is made from a single nitinol strand, the overall length of stent can change dramatically depending on the degree of stenosis present.This usually results in a longer configuration to the stent, resulting in a change of the interstices¿ diamond shape, instead of the long axis being oriented perpendicular to the stent length, they become parallel to the stent length.In this case, the opposite appears to have taken place.The diamond shape of the interstices are still oriented perpendicular to the stent length, but are compressed in the cranial/caudal dimension resulting in a significant decrease in the size of the interstices and increased density of the stent lattice.The stent diameter should not increase greater than the intrinsic diameter of the stent unless a stent fracture has occurred, allowing it to widen, which would in turn allow foreshortening to occur without much resistance.Given the amount of debris that is present in the stent, a stent fracture is not possible to exclude, but there is no comment in the complaint report regarding a fracture.A stent compressed in a cranial/caudal direction to this extent, without fracture, would have a significant amount of force trying to return the stent to its native design.The debris in the stent could potentially be inhibiting this from occurring.From this single image, it is not possible to determine why or exactly how the stent ended up in the configuration.Fortunately, the operator was able to remove the stent and place a new stent in appropriate position.Given the stent was described as ¿floating in the bulb,¿ it appears as the stent shortened as it moved cranial to the stenosis and was likely no longer providing any relief to the duodenal stenosis.Document review: prior to distribution all evo-22-27-6-d devices are subject to visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.The evo-22-27-6-d device from unknown lot number, a review of the relevant manufacturing records cannot be conducted.Ifu review: as per the instructions for use, ifu0053-10 which accompanies this device, it states that potential complications include stent misplacement and/or migration.As per the instructions for use, ifu0053-10 precautions state "a complete diagnostic evaluation must be performed prior to use to determine proper stent size." there is evidence to suggest that the customer did not follow the instructions for use (ifu0053-10).Root cause: there was no device returned for investigation and it was not possible to determine why or exactly how the stent ended up in the configuration from the image review, therefore a definite root cause could not be determined.However, a possible root cause based upon engineering input states that based on the doctor and his superiors statement that the stent was deployed where the stricture ended confirms that this was fluoroscopically verified and therefore it¿s likely the device moved from the correct location while deploying the stent.The root cause is related to user error, as the customer did not follow the instructions for use, as per image review.Summary: there is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.Complaints of this nature will continue to be monitored for potential emerging trends.
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