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COOK IRELAND LTD EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED; MUM STENT, METALIC EXPANDABLE, DUODENAL
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| Catalog Number EVO-22-27-9-D |
| Device Problem
Material Frayed (1262)
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| Patient Problem
No Known Impact Or Consequence To Patient (2692)
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| Event Date 10/04/2017 |
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Event Type
malfunction
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Manufacturer Narrative
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Pma/510(k) # "k101530 and k163468" (b)(4).Investigation pending, a follow up mdr will be submitted with the investigation conclusions.
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Event Description
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Initial mdr is being submitted based on the device malfunction precedence: ¿stent fracture/wire fracture".As reported to customer relations: " on (b)(6) 2016 dr.(b)(6) and the prior cook dm ((b)(6)) placed a fully uncovered evolution duodenal self expanding metal stent in the second part of the duodenum.The stent placement was good and the patient did well.On (b)(6) 2017 dr.(b)(6) went back in and placed a second evolution uncovered stent inside the pre-existing stent.The case went well and there were no complication.Currently i [district manager] was speaking to the doctor regarding the construction of our metal stents (single nitinol wire) when he brought up a case where he witnessed frayed wires from the stent placed back in (b)(6) 2016.He [the physician] has provided photos from that second procedure more recently in (b)(6) 2017.He [the physician] wanted to make it clear he was not complaining at all, he [the physician] just thought our engineers should see the photo's from the second procedure where you can clearly see the frayed wires of the previously placed evolution stent." additional information per the emailed attachments from the facility received on 31jan2018: description of procedure: informed consent was obtained with the benefits, risks, and alternatives to upper gi endoscopy explained, including the risk of perforation, and the patient agreed to proceed.Immediately prior to sedation for endoscopy the patients asa classification was class 3: severe systemic disease, but not incapacitating.Prior to the procedure the patients mallampati score was class 1: soft palate, uvula, fauces and pillars visible.Patients last upper endoscopy was (b)(6) 2017 2:05:00 pm.No contraindications were noted on physical exam.The procedure was performed with the patient in the left lateral decubitus position.The instrument was inserted to the second part of the duodenum.The patient tolerated the procedure well.There were no complications.Findings: esophagus: dh: 45 cm from the incisors, scj: 45 cm from the incisors, gej: 45 cm from the incisors, la grade a esophagus, esophagus otherwise normal.Stomach: food in stomach.Small ulcers in stomach, likely due to mucosal trauma from the prior stent.The prior duodenal stent was in position across the pylorus into the stomach.The lumen was mostly obstructed with tissue ingrowth.The tissue at the pylorus was biopsied to evaluate for malignancy vs.Granulation tissue due to the stent (jar 1).The regular egd scope could not be passed through the stricture.The xp 180 scope was used to cross the stricture and examine the duodenum.A long wire was inserted through the scope into the duodenum distal to the prior stent.The scope was withdrawn.A 22 mm x 9 cm uncovered cook evolution stent was passed over the wire under direct visualization and fluoroscopy across the stricture.The sent was deployed under direct visualization and fluoroscopy.The stent was in good position at the end of the case across the stricture.Duodenum: there was tissue ingrowth through the stent mesh, but the lumen of the stent after the stricture appeared open.The duodenum distal to the stent appeared open.Prior to the new stent being placed, biopsies were taken of the tissue ingrowth within the stent in the duodenum bulb to evaluate for malignancy vs.Granulation tissue to the stent (jar 2).There were several duodenum bulb ulcers within the previously stented area.Complications: none.Estimated blood loss: minimal.Impression: this is a (b)(6) m with stage 4 metastatic pancreatic cancer with prior duodenum stent placement undergoing egd for duodenum stent insertion.Stricture at pylorus.Bx taken as above.Duodenum stent successfully placed across stricture as above.Grade a erosive esophagitis.Recommendations: return to ward for ongoing care.Await biopsy results.If you have not been contacted within 2 weeks, please call dr, calcagno at 915-742-2222 to discuss the results.Start protonix 40 mg twice daily, 30 min before breakfast and dinner, clears tonight.Advance diet as toleration tomorrow.(b)(4).
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Manufacturer Narrative
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Complaints of this nature will continue to be monitored for potential emerging trends.Pma/510(k) # "k101530 and k163468".Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to as follows: importer site contact and address: (b)(6) cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195 importer site establishment registration number: 3005580113 problem statement: as reported to customer relations: " on (b)(6) 2016 dr.(b)(6) and the prior cook dm (b)(6) placed a fully uncovered evolution duodenal self expanding metal stent in the second part of the duodenum.The stent placement was good and the patient did well.On (b)(6) 2017 dr.(b)(6) went back in and placed a second evolution uncovered stent inside the pre-existing stent.The case went well and there were no complication.Currently i [district manager] was speaking to the doctor regarding the construction of our metal stents (single nitinol wire) when he brought up a case where he witnessed frayed wires from the stent placed back in (b)(6) of 2016.He [the physician] has provided photos from that second procedure more recently in (b)(6) 2017.He [the physician] wanted to make it clear he was not complaining at all, he [the physician] just thought our engineers should see the photo's from the second procedure where you can clearly see the frayed wires of the previously placed evolution stent." additional information per the emailed attachments from the facility received on 31jan2018: description of procedure: informed consent was obtained with the benefits, risks, and alternatives to upper gi endoscopy explained, including the risk of perforation, and the patient agreed to proceed.Immediately prior to sedation for endoscopy the patients asa classification was class 3: severe systemic disease, but not incapacitating.Prior to the procedure the patients mallampati score was class 1: soft palate, uvula, fauces and pillars visible.Patients last upper endoscopy was (b)(6) 2017 2:05:00pm.No contraindications were noted on physical exam.The procedure was performed with the patient in the left lateral decubitus position.The instrument was inserted to the second part of the duodenum.The patient tolerated the procedure well.There were no complications.Findings: esophagus: dh: 45cm from the incisors.Scj: 45cm from the incisors.Gej: 45cm from the incisors.La grade a esophagus.Esophagus otherwise normal.Stomach: food in stomach.Small ulcers in stomach, likely due to mucosal trauma from the prior stent.The prior duodenal stent was in position across the pylorus into the stomach.The lumen was mostly obstructed with tissue ingrowth.The tissue at the pylorus was biopsied to evaluate for malignancy vs.Granulation tissue due to the stent (jar 1).The regular egd scope could not be passed through the stricture.The xp 180 scope was used to cross the stricture and examine the duodenum.A long wire was inserted through the scope into the duodenum distal to the prior stent.The scope was withdrawn.A 22mmx9cm uncovered cook evolution stent was passed over the wire under direct visualization and fluoroscopy across the stricture.The sent was deployed under direct visualization and fluoroscopy.The stent was in good position at the end of the case across the stricture.Duodenum: there was tissue ingrowth through the stent mesh, but the lumen of the stent after the stricture appeared open.The duodenum distal to the stent appeared open.Prior to the new stent being placed, biopsies were taken of the tissue ingrowth within the stent in the duodenum bulb to evaluate for malignancy vs.Granulation tissue to the stent (jar 2).There were several duodenum bulb ulcers within the previously stented area.Complications: none estimated blood loss: minimal.Impression: this is a 64 year old m with stage 4 metastatic pancreatic cancer with prior duodenum stent placement undergoing egd for duodenum stent insertion.Stricture at pylorus.Bx taken as above.Duodenum stent successfully placed across stricture as above.Grade a erosive esophagitis.Recommendations: return to ward for ongoing care await biopsy results.If you have not been contacted within 2 weeks, please call dr.(b)(6) to discuss the results.Start protonix 40mg twice daily, 30 min before breakfast and dinner, clears tonight.Advance diet as toleration tomorrow.Procedure codes: egd with biopsy (43239).Egd withy dilation and stent placement (43266).Device evaluation: the evo-22-27-9-d device of unknown lot number was implanted in the patient and is therefore unavailable for evaluation.With the information provided a document based investigation was carried out.The patient had the following pre-existing conditions: gastric outlet obstruction stage 4 metastatic pancreatic cancer.The following additional information was also received: the proximal portion (stent contained in the stomach / pylorus) was the damaged part of the stent.Images were provided to support the complaint investigation.The customer complaint is confirmed, as on review of the imaging provided, the breakage of the stent through the pylorus can be seen.Root cause: this may have occurred as a result of fatigue caused by peristaltic motion in the duodenal tract over the 13 months it was implanted.Long-term patency of this device has not been established.Document review: as the lot number of the complaint stent is unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all evo-22-27-9-d devices are subjected to visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.Ifu review: as per the instructions for use, ¿visually inspect with particular attention to kinks, bend and breaks.If an abnormality is detected that would prohibit proper working condition, do not use.¿ in addition, the instructions for use also states: "long-term patency of this device has not been established.Periodic evaluation is advised." summary: the customer complaint is confirmed, as on review of the imaging provided, the breakage of the stent through the pylorus can be seen.From the information provided, there have been no adverse effects to the patient as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
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Event Description
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This follow up mdr is being submitted to update the investigation results.Initial mdr is being submitted based on the device malfunction precedence: ¿stent fracture/wire fracture".As reported to customer relations: " on (b)(6)2016 dr.(b)(6) and the prior cook dm (b)(6) placed a fully uncovered evolution duodenal self expanding metal stent in the second part of the duodenum.The stent placement was good and the patient did well.On (b)(6)2017 dr.(b)(6) went back in and placed a second evolution uncovered stent inside the pre-existing stent.The case went well and there were no complication.Currently i [district manager] was speaking to the doctor regarding the construction of our metal stents (single nitinol wire) when he brought up a case where he witnessed frayed wires from the stent placed back in (b)(6) 2016.He [the physician] has provided photos from that second procedure more recently in (b)(6) 2017.He [the physician] wanted to make it clear he was not complaining at all, he [the physician] just thought our engineers should see the photo's from the second procedure where you can clearly see the frayed wires of the previously placed evolution stent." additional information per the emailed attachments from the facility received on 31jan2018: description of procedure: informed consent was obtained with the benefits, risks, and alternatives to upper gi endoscopy explained, including the risk of perforation, and the patient agreed to proceed.Immediately prior to sedation for endoscopy the patients asa classification was class 3: severe systemic disease, but not incapacitating.Prior to the procedure the patients mallampati score was class 1: soft palate, uvula, fauces and pillars visible.Patients last upper endoscopy was (b)(6) 2017 2:05:00pm.No contraindications were noted on physical exam.The procedure was performed with the patient in the left lateral decubitus position.The instrument was inserted to the second part of the duodenum.The patient tolerated the procedure well.There were no complications.Findings: esophagus: dh: 45cm from the incisors.Scj: 45cm from the incisors.Gej: 45cm from the incisors.La grade a esophagus.Esophagus otherwise normal.Stomach: food in stomach.Small ulcers in stomach, likely due to mucosal trauma from the prior stent.The prior duodenal stent was in position across the pylorus into the stomach.The lumen was mostly obstructed with tissue ingrowth.The tissue at the pylorus was biopsied to evaluate for malignancy vs.Granulation tissue due to the stent (jar 1).The regular egd scope could not be passed through the stricture.The xp 180 scope was used to cross the stricture and examine the duodenum.A long wire was inserted through the scope into the duodenum distal to the prior stent.The scope was withdrawn.A 22mmx9cm uncovered cook evolution stent was passed over the wire under direct visualization and fluoroscopy across the stricture.The sent was deployed under direct visualization and fluoroscopy.The stent was in good position at the end of the case across the stricture.Duodenum: there was tissue ingrowth through the stent mesh, but the lumen of the stent after the stricture appeared open.The duodenum distal to the stent appeared open.Prior to the new stent being placed, biopsies were taken of the tissue ingrowth within the stent in the duodenum bulb to evaluate for malignancy vs.Granulation tissue to the stent (jar 2).There were several duodenum bulb ulcers within the previously stented area.Complications: none estimated blood loss: minimal.Impression: this is a 634 year old m with stage 4 metastatic pancreatic cancer with prior duodenum stent placement undergoing egd for duodenum stent insertion.Stricture at pylorus.Bx taken as above.Duodenum stent successfully placed across stricture as above.Grade a erosive esophagitis.Recommendations: return to ward for ongoing care await biopsy results.If you have not been contacted within 2 weeks, please call dr.(b)(6) to discuss the results.Start protonix 40mg twice daily, 30 min before breakfast and dinner, clears tonight.Advance diet as toleration tomorrow.Procedure codes: egd with biopsy (43239) egd withy dilation and stent placement (43266).
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Manufacturer Narrative
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Pma/510(k) # "k101530 and k163468." cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(6).Cook medical incorporated (cmi), 1025 acuff road, p.O box 4195, bloomington, indiana 47402-4195.Importer site establishment registration number: (b)(4).Updated information: root cause: this may have occurred as a result of fatigue caused by peristaltic motion in the duodenal tract over the 13 months it was implanted.Long-term patency of this device has not been established.Note: a further discussion was held with engineering on 14-may-2018.It was concluded that the stent was not corrosion resistant for the length of time the stent was in the patient.H3 other text : pma/510(k) # "k101530 and k163468" cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(6).Cook medical incorporated (cmi), 1025 acuff road, p.O box 4195, bloomington, indiana 47402-4195.Importer site establishment registration number: (b)(4).Updated information: root cause: this may have occurred as a result of fatigue caused by peristaltic motion in the duodenal tract over the 13 months it was implanted.Long-term patency of this device has not been established.Note: a further discussion was held with engineering on 14-may-2018.It was concluded that the stent was not corrosion resistant for the length of time the stent was in the patient.
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Event Description
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This follow up mdr is being submitted to update the investigation.Initial mdr is being submitted based on the device malfunction precedence: ¿stent fracture/wire fracture." as reported to customer relations: " on (b)(6) 2016 dr.(b)(6) and the prior cook dm (b)(6) placed a fully uncovered evolution duodenal self expanding metal stent in the second part of the duodenum.The stent placement was good and the patient did well.On (b)(6) 2017 dr.(b)(6) went back in and placed a second evolution uncovered stent inside the preexisting stent.The case went well and there were no complication.Currently i [district manager] was speaking to the doctor regarding the construction of our metal stents (single nitinol wire) when he brought up a case where he witnessed frayed wires from the stent placed back in (b)(6) of 2016.He [the physician] has provided photos from that second procedure more recently in october 2017.He [the physician] wanted to make it clear he was not complaining at all, he [the physician] just thought our engineers should see the photo's from the second procedure where you can clearly see the frayed wires of the previously placed evolution stent." additional information per the emailed attachments from the facility received on 31jan2018: description of procedure: informed consent was obtained with the benefits, risks, and alternatives to upper gi endoscopy explained, including the risk of perforation, and the patient agreed to proceed.Immediately prior to sedation for endoscopy the patients asa classification was class 3: severe systemic disease, but not incapacitating.Prior to the procedure the patients mallampati score was class 1: soft palate, uvula, fauces and pillars visible.Patients last upper endoscopy was (b)(6) 2017 2:05:00pm.No contraindications were noted on physical exam.The procedure was performed with the patient in the left lateral decubitus position.The instrument was inserted to the second part of the duodenum.The patient tolerated the procedure well.There were no complications.Findings: esophagus: dh: 45cm from the incisors.Scj: 45cm from the incisors.Gej: 45cm from the incisors.La grade a esophagus.Esophagus otherwise normal.Stomach: food in stomach.Small ulcers in stomach, likely due to mucosal trauma from the prior stent.The prior duodenal stent was in position across the pylorus into the stomach.The lumen was mostly obstructed with tissue ingrowth.The tissue at the pylorus was biopsied to evaluate for malignancy vs.Granulation tissue due to the stent (jar 1).The regular egd scope could not be passed through the stricture.The xp 180 scope was used to cross the stricture and examine the duodenum.A long wire was inserted through the scope into the duodenum distal to the prior stent.The scope was withdrawn.A 22mmx9cm uncovered cook evolution stent was passed over the wire under direct visualization and fluoroscopy across the stricture.The sent was deployed under direct visualization and fluoroscopy.The stent was in good position at the end of the case across the stricture.Duodenum: there was tissue ingrowth through the stent mesh, but the lumen of the stent after the stricture appeared open.The duodenum distal to the stent appeared open.Prior to the new stent being placed, biopsies were taken of the tissue ingrowth within the stent in the duodenum bulb to evaluate for malignancy vs.Granulation tissue to the stent (jar 2).There were several duodenum bulb ulcers within the previously stented area.Complications: none.Estimated blood loss: minimal.Impression: this is a 634-year-old m with stage 4 metastatic pancreatic cancer with prior duodenum stent placement undergoing egd for duodenum stent insertion.Stricture at pylorus.Bx taken as above.Duodenum stent successfully placed across stricture as above.Grade a erosive esophagitis.Recommendations: return to ward for ongoing care await biopsy results.If you have not been contacted within 2 weeks, please call dr (b)(6) at 9157422222 to discuss the results.Start protonix 40mg twice daily, 30 min before breakfast and dinner, clears tonight.Advance diet as toleration tomorrow.Procedure codes: egd with biopsy (43239) and egd withy dilation and stent placement (43266).
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