COOK IRELAND LTD EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED; MQR STENT, COLONIC METALLIC EXPANDABLE
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Catalog Number UNKNOWN |
Device Problems
Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Occlusion (1984); Obstruction/Occlusion (2422)
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Event Date 01/26/2020 |
Event Type
Injury
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Manufacturer Narrative
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Pma/510(k) #: k163468.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
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Event Description
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Cao-2020, evo-c, colon metal stents as a bridge to surgery had no significant effects on the perineural invasion: a retrospective study.Stent placement was performed under both endoscopic and fluoroscopic guidance.The main types of colon stents are wilson cook and (b)(4) scientific.The stent size and length were chosen according to the measured length of the obstruction, and uncovered sems was used as a bridge to surgery.One patient developed an obstruction again after stent implantation, and stent re-insertion was performed.
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Event Description
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Supplemental report is being submitted due to the completion of the investigation.
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Manufacturer Narrative
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Pma/510(k) #: k163468.Device evaluation: the colonic devices involved in this complaint was not returned to cirl for evaluation.With the information provided, a document based investigation will be complete.This file was created from the attached journal article.Reference (b)(4).Complaint files (b)(4) were opened as a result of this paper.This file (b)(4) was opened to investigate obstruction.Lab evaluation: n/a.Documents review including ifu review: as the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution evo colonic devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.As the evo colonic devices from unknown lot number, a review of the relevant manufacturing records cannot be conducted.As per the instructions for use, ifu0052-11, which accompanies this device it informs the user about the potential complications "additional complications include, but are not limited to : tumor ingrowth or overgrowth , stent occlusion ".There is no evidence to suggest that the customer did not follow the instructions for use.Image review: n/a.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed the patient¿s pre-existing condition.From the information provided it is known that the patient had colorectal cancer.Summary: complaint is confirmed based on the customers testimony.Complaints of this nature will continue to be monitored for potential emerging trends.
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Manufacturer Narrative
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Pma/510(k) #: k163468.Device evaluation: the colonic devices involved in this complaint was not returned to cirl for evaluation.With the information provided, a document based investigation will be complete.This file was created from the journal article."cao-2020".Complaint files pr (b)(4) and pr (b)(4) (3001845648-2021-00122) were opened as a result of this paper.This file pr 319986 (3001845648-2021-00121) was opened to investigate obstruction.Documents review including ifu review: as the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution evo colonic devices are subjected to a visual inspection and functional checks to ensure device integrity.As the evo colonic devices from unknown lot number, a review of the relevant manufacturing records cannot be conducted.As per the instructions for use, ifu0052, which accompanies this device it informs the user about the potential complications "additional complications include, but are not limited to : tumor ingrowth or overgrowth , stent occlusion ".There is no evidence to suggest that the customer did not follow the instructions for use.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed the patient¿s pre-existing condition.From the information provided it is known that the patient had colorectal cancer.Based on medical advisor opinion, it is possible that its due to "conditions occurring during device use and pre-existing conditions." summary: complaint is confirmed based on the customers testimony.As per medical advisor, patient patient outcome was "require hospitalisation/prolong hospitalisation" complaints of this nature will continue to be monitored for potential emerging trends.
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Event Description
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Supplemental report is being submitted due to a corrections to multiple fields including imdfr codes.
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Search Alerts/Recalls
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