MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED; ESW PROSTHESIS, ESOPHAGEAL

Catalog Number UNKNOWN

Device Problem Migration (4003)

Patient Problems No Consequences Or Impact To Patient (2199); Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Pma/510(k) #: as the rpn is unknown, providing both 510k numbers for partially and fully covered evolution esophageal devices k162717.

Event Description

Literature review title: ''early pain detection and management after esophageal metal stent placement in incurable cancer patients: a prospective observational cohort study'' reijm et al 2016.Sixty-five patients were treated with a sems for a malignant stricture of the esophagus (n=58) or gastric tube (n=7), including 6 patients with a concomitant fistula.''five stent types were used: partially covered ultraflex stents (boston scientific), partially covered evolution stents (cook medical), fully covered hanaro stents (mi tech) and partially as well as fully covered wallflex stents (boston scientific).6 cases distal migration of stent observed with median of 3.5 days after insertion.All were managed endoscopically.2 of which stent was removed and a new metal stent deployed.Remaining 4 cases stent repositioned using grasping forceps.''five stent types were used: partially covered ultraflex stents (boston scientific), partially covered evolution stents (cook medical), fully covered hanaro stents (mi tech) and partially as well as fully covered wallflex stents (boston scientific).We cannot confirm that the cook evolution stent was related to this specific adverse event so this is a conservative assessment.(b)(4).

Event Description

Literature review title: ''early pain detection and management after esophageal metal stent placement in incurable cancer patients: a prospective observational cohort study'' reijm et al 2016.Sixty-five patientswere treated with a sems for amalignant stricture of the esophagus (n=58) or gastric tube (n=7), including 6 patients with a concomitant fistula.''five stent types were used: partially covered ultraflex stents (boston scientific), partially covered evolution stents (cook medical), fully covered hanaro stents (mi tech) and partially as well as fully covered wallflex stents (boston scientific).6 cases distal migration of stent observed with median of 3.5 days after insertion.All were managed endoscopically 2 of which stent was removed and a new metal stent deployed.Remaining 4 cases stent repositioned using grasping forceps.Five stent types were used: partially covered ultraflex stents (boston scientific), partially covered evolution stents (cook medical), fully covered hanaro stents (mi tech) and partially as well as fully covered wallflex stents (boston scientific).We cannot confirm that the cook evolution stent was related to this this specific adverse event so this is a conservative assessment moc 09-dec-2019.

Manufacturer Narrative

Pma/510(k)#: k162717.Device evaluation: the evo device of unknown lot number was not returned to cook ireland for evaluation.With the information provided, document based investigation was conducted.This file was created from the attached journal article.A total of sixty five patients were identified in this study.From "table 1 baseline characteristics of 65 patients" multiple stent were used:boston ultraflex (pc1) (small body)18; cook evolution (pc1) (wide body)14)m.I.Tech hanaro stent (fc2) (small body)9; bostonwallflex (fc2) (small body)10 and bostonwallflex (pc1) (small body)14.This file captures six cases migration of stent observed and intervention required.Documents review including ifu review: as the evo (esophageal metal) device from unknown lot number, a review of the relevant manufacturing records cannot be conducted.Prior to distribution all evo(esophageal metal) 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.As per the instructions for use, ifu0061-6, which informs the user about the potential complications "additional complications include, but are not limited to : perforation, hemorrhage, aspiration, reflux, fever, infection, allergic reaction to medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest.Additional complication include, but are not limited to: stent misplacement and/or migration; tumor ingrowth or overgrowth; esophageal ulceration and erosion; nausea; chest or retrosternal pain; foreign body sensation; food bolus impaction; gasbloat; sensitivity to metal components; fistula involving trachea, bronchi or pleural space; intestinal obstruction secondary to migration; mediastinitis or peritonitis; airway compression; tracheal obstruction.On review of the information provided, there is no evidence to suggest that the user 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 to patient condition related, as per instructions for use, stent migration is listed as a complication following the placement of this device.Summary: complaint is confirmed based on customer testimony.Patient outcome is unknown.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED
• Type of Device: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9494118
• MDR Text Key: 188138285
• Report Number: 3001845648-2019-00751
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 12/05/2019
• Supplement Dates FDA Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention