MAUDE Adverse Event Report: COOK IRELAND LTD UNKNOWN; MUM STENT, METALIC EXPANDABLE, DUODENAL

Catalog Number UNKNOWN

Device Problem Occlusion Within Device (1423)

Patient Problems Occlusion (1984); Vomiting (2144)

Event Type  Injury  

Manufacturer Narrative

(b)(4).As per (b)(4) product manager feedback: ¿for (b)(4) the complaint is stent occlusion due to overgrowth ¿ a complication mentioned in the ifu.As per (b)(4) r&d engineer feedback: "the article details stent occlusion from tissue ingrowth and food debris for the first stent, ifu contains potential complications tumor ingrowth or overgrowth, stent occlusion.Investigation is pending.A follow up report will be submitted within 30 days with the investigation conclusions.

Event Description

Report is being submitted for the event: stent occlusion from tissue ingrowth and food debris.Obstruction of the afferent or efferent limbs of a gastrojejunal anastomosis is potential complication after pancreaticoduodenectomy (pd) resulting in either gastric outlet obstruction or afferent limb syndrome.Four (4) patients underwent metal stent placement for gastrojejunal obstruction after pd for pancreatic cancer.Literature source: wilson t.Kwonga, syed m.Fehmia, andrew m.Lowyb, thomas j.Savidesa 'enteral stenting for gastric outlet obstruction and afferent limb syndrome following pancreaticoduodenectomy', annals of gastroenterology (2014) 27, 413-417.Study location: university of california, san diego health sciences, la jolla, ca, usa.The reported case is as follows: a (b)(6) man underwent pd for t3n1 pancreatic adenocarcinoma with negative margins.He developed recurrent disease and eleven months following resection, he developed inability to tolerate solid foods.Computed tomography (ct) scan revealed a dilated stomach consistent with gastric outlet obstruction.Upper endoscopy demonstrated a tight angulation at the efferent limb anastomosis (fig.1).An uncovered metal stent (27 mm × 60 mm, evolution duodenal stent, cook medical, (b)(4)) was placed in the efferent limb and the patient was subsequently able to resume a regular diet.Positron emission tomography ct scan demonstrated malignant recurrence surrounding the stent (fig.2).Five weeks later, he developed recurrent vomiting.Repeat endoscopy revealed stent occlusion from tissue ingrowth and food debris.A second uncovered metal stent (22 mm × 90 mm, boston scientific wallflex duodenal stent, (b)(4)) was placed within the existing stent with resolution of his symptoms.Four weeks later, the patient developed elevated total bilirubin 5.9 mg/dl, and alkaline phosphatase 488 u/l.An upper gi series demonstrated a patent efferent limb without opacification of the afferent limb, consistent with afferent limb syndrome.Esophagogastroduodenoscopy (egd) revealed a strictured afferent limb and an uncovered metal stent (22 mm × 90 mm, evolution duodenal stent, cook medical, (b)(4)) was placed (fig.3).The patient¿s bilirubin normalized after stent placement.Six weeks later, he developed bilious emesis.Endoscopic and fluoroscopic evaluation revealed a narrowing of the distal efferent limb stent followed by a 2 cm stricture immediately beyond the stent.A longer 22 mm × 120 mm stent (evolution duodenal stent, cook medical, (b)(4)) was placed through the existing stents (fig.4).Despite chemotherapy, the patient developed omental metastases and an enlarging porta hepatis mass.The patient passed away 3 weeks after stent placement.

Manufacturer Narrative

Cook (b)(4) ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Exemption number: e2016031.(b)(4).Importer site establishment registration number: (b)(4).In consultation with the cirl product manager (b)(4) the following summary was clarified in relation to the above article information: stent # 1 an uncovered metal stent (27 mm × 60 mm, evolution duodenal stent, cook medical, (b)(4) was placed in the efferent limb.Stent # 2 placed was a boston uncovered metal stent (22 mm × 90 mm, boston scientific wallflex duodenal stent, (b)(4) it is assumed that ¿narrowing of the distal efferent limb stent¿ refers to this stent, as the 1st stent (uncovered metal stent (27 mm × 60 mm, evolution duodenal stent) had occluded.Stent # 3 ¿ an uncovered metal stent (22 mm × 90 mm, evolution duodenal stent, cook medical, (b)(4) was placed in the afferent limb - no complaint.Stent # 4 - a longer 22 mm × 120 mm stent (evolution duodenal stent, cook medical, (b)(4) was placed stent-in-stent which is considered to be off label and is investigated under a different pr.This investigation is in relation to stent # 1 which was placed in the efferent limb.Pre-existing conditions of the patient were reported as ¿pancreatic adenocarcinoma with negative margins.¿ the following clinical input was requested: ¿in your clinical opinion was this patient¿s death device-related?¿ to which the following response was received: ¿there is not enough information to draw that conclusion.¿ as per product manager feedback: ¿for stent # 1 the complaint is stent occlusion due to overgrowth ¿ a complication mentioned in the ifu.As per r&d engineer feedback: "the article details stent occlusion from tissue ingrowth and food debris for the first stent, ifu contains potential complications tumor ingrowth or overgrowth, stent occlusion, suggested failure mode: stent occlusion due to ingrowth and/or overgrowth" the device involved in this complaint was not available for return to cook ireland for evaluation.However, the cirl r & d engineer provided additional comments "there is no evidence of device malfunction.Malignant recurrence surrounding the stent is a potential complication of duodenal stenting ¿ which essentially means tissue overgrowth due to disease progression as listed in ifu.This complication would occur regardless of the brand of uncovered duodenal stent that would be placed in the patient." as the device has not been returned the cause of the complaint could not be conclusively determined.The customer complaint is confirmed based on the customers¿ testimony.As the lot number was not provided, a review of manufacturing instructions could not be complete.Prior to distribution all evo 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.As per the instructions for use, ifu0053-8 additional complications include, but are not limited to: tissue ingrowth and overgrowth.It was reported that ¿5 weeks later developed recurrent vomiting and repeated endoscopy confirmed stent occlusion from tissue ingrowth and food debris.¿ complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This follow up is being submitted to include the investigation occlusions report is being submitted for the event: stent occlusion from tissue ingrowth and food debris.Obstruction of the afferent or efferent limbs of a gastrojejunal anastomosis is potential complication after pancreaticoduodenectomy (pd) resulting in either gastric outlet obstruction or afferent limb syndrome.4 patients underwent metal stent placement for gastrojejunal obstruction after pd for pancreatic cancer.Literature source: wilson t.Kwonga, syed m.Fehmia, andrew m.Lowyb, thomas j.Savidesa 'enteral stenting for gastric outlet obstruction and afferent limb syndrome following pancreaticoduodenectomy', annals of gastroenterology (2014) 27, 413-417.Study location: university of california, san diego health sciences, la jolla, ca, usa the reported case is as follows: a (b)(6) year-old man underwent pd for t3n1 pancreatic adenocarcinoma with negative margins.He developed recurrent disease and eleven months following resection, he developed inability to tolerate solid foods.Computed tomography (ct) scan revealed a dilated stomach consistent with gastric outlet obstruction.Upper endoscopy demonstrated a tight angulation at the efferent limb anastomosis.An uncovered metal stent (27 mm × 60 mm, evolution duodenal stent, cook medical, (b)(4) was placed in the efferent limb and the patient was subsequently able to resume a regular diet.Positron emission tomography ct scan demonstrated malignant recurrence surrounding the stent.Five weeks later, he developed recurrent vomiting.Repeat endoscopy revealed stent occlusion from tissue ingrowth and food debris.A second uncovered metal stent (22 mm × 90 mm, boston scientific wallflex duodenal stent, (b)(4) was placed within the existing stent with resolution of his symptoms.Four weeks later, the patient developed elevated total bilirubin 5.9 mg/dl, and alkaline phosphatase 488 u/l.An upper gi series demonstrated a patent efferent limb without opacification of the afferent limb, consistent with afferent limb syndrome.Esophagogastroduodenoscopy (egd) revealed a strictured afferent limb and an uncovered metal stent (22 mm × 90 mm, evolution duodenal stent, cook medical, (b)(4) was placed.The patient¿s bilirubin normalized after stent placement.Six weeks later, he developed bilious emesis.Endoscopic and fluoroscopic evaluation revealed a narrowing of the distal efferent limb stent followed by a 2 cm stricture immediately beyond the stent.A longer 22 mm × 120 mm stent (evolution duodenal stent, cook medical, (b)(4) was placed through the existing stents.Despite chemotherapy, the patient developed omental metastases and an enlarging porta hepatis mass.The patient passed away 3 weeks after stent placement.

• Brand Name: UNKNOWN
• Type of Device: MUM STENT, METALIC EXPANDABLE, DUODENAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer Contact: tracy o'sullivan ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6328689
• MDR Text Key: 67380748
• Report Number: 3001845648-2017-00045
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/25/2017
• Event Location: Hospital
• Date Manufacturer Received: 01/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR