MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED; MUM STENT, METALIC EXPANDABLE, DUODENAL

Model Number G48027

Device Problems Break (1069); Activation Problem (4042)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/28/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k)#: k163468.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Stent cannot be deployed.Patient outcome: "a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence." patient/event info - notes: what is the reorder number of the wire guide used with this device? (b)(4).If not with the device in question, how was the procedure finished? with another same device to complete the procedure.For complaints occurring during use (once in contact with patient) also ask: what is the endoscope manufacturer and model number that was used during the procedure? olympus gf-h260ai.Had dilation of the stricture been performed prior to stent placement? no.What was the diameter of the stricture at the time of stent placement (in mm)? 1.4cm.What was the length of the stricture at the time of stent placement (in cm)? 6cm.Please describe the location in the body where the stent was to be placed.Pylorus.Was resistance encountered when advancing the wire guide through the stricture? no.Was resistance encountered when advancing the introducer and stent into position? no.Did any section of the device detach inside the patient? no.After placement, was stent position verified? if yes, please describe how.N/a.After placement, was the endoscope advanced through the stent? n/a.Please estimate amount of time the stent was in place prior to this occurrence.N/a.Did the patient undergo chemotherapy or radiation treatments after stent placement? n/a.

Event Description

Stent cannot be deployed.Patient outcome: "a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence." patient/event info - notes: 1.What is the reorder number of the wire guide used with this device? metii-35-480; cook metii-35-480.2.If not with the device in question, how was the procedure finished? with another same device to complete the procedure.For complaints occurring during use (once in contact with patient) also ask: 3.What is the endoscope manufacturer and model number that was used during the procedure? olympus gf-h260ai.Gf-h260ai.4.Had dilation of the stricture been performed prior to stent placement? no.5.What was the diameter of the stricture at the time of stent placement (in mm)? 1.4cm.Mm) 1.4cm.6.What was the length of the stricture at the time of stent placement (in cm)? 6cm.Cm) 6cm.7.Please describe the location in the body where the stent was to be placed.Pylorus.8.Was resistance encountered when advancing the wire guide through the stricture? no.9.Was resistance encountered when advancing the introducer and stent into position? no.10.Did any section of the device detach inside the patient? no.11.After placement, was stent position verified? if yes, please describe how.N/a.12.After placement, was the endoscope advanced through the stent? n/a.13.Please estimate amount of time the stent was in place prior to this occurrence.N/a.14.Did the patient undergo chemotherapy or radiation treatments after stent placement? n/a.

Manufacturer Narrative

Pma/510(k)#: k163468.Device evaluation: the evo-22-27-12-d device of lot number c1635056 involved in this complaint was returned for evaluation, with the original packaging.With the information provided, a physical examination and document based investigation was conducted.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on the 30th july 2020.In summary the following results were observed in the lab evaluation: handle was actuating without issue, however unable to deploy the stent.Handle was opened and shuttle cap was found to be broken.No other defects observed.Safety wire returned separately to device.Documents review including ifu review: prior to distribution all evo-22-27-12-d 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.A review of the manufacturing records for evo-22-27-12-d device of lot number c1635056 did not reveal any discrepancies that could have contributed to this issue.There is no evidence to suggest that this issue affects the entire lot #c1635056 ; upon review of complaints this failure mode has not occurred previously with this lot #c1635056.The instructions for use ifu0053-10 which accompanies this device instructs the user to "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".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 as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to material failure.Summary: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaint is confirmed as the failure was verified in the laboratory.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
• Type of Device: MUM STENT, METALIC EXPANDABLE, DUODENAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10326987
• MDR Text Key: 242645725
• Report Number: 3001845648-2020-00456
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 10827002480275
• UDI-Public: (01)10827002480275(17)210725(10)C1635056
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2021
• Device Model Number: G48027
• Device Catalogue Number: EVO-22-27-12-D
• Device Lot Number: C1635056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/28/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/28/2020
• Initial Date FDA Received: 07/27/2020
• Supplement Dates Manufacturer Received: 06/28/2020
• Supplement Dates FDA Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1