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

Model Number	G48027
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # : k163468.Device evaluation: two evo-22-27-12-d devices of lot number c1570803 involved in this complaint were returned for evaluation, with its original packaging.With the information provided, a physical examination and document based investigation was conducted.Lab evaluation: the devices involved in the complaint were evaluated in the laboratory on 26th july 2019.No defect found in the laboratory, devices functioned as intended 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 cook (b)(4).A review of the manufacturing records for evo-22-27-12-d device of lot number c1570803 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 #c1570803; upon review of complaints this failure mode has not occurred previously with this lot #c1570803.The instructions for use ifu0053-9 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 ifu0053-9.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 potentially to patient anatomy as the device when returned for evaluation functioned as intended.Summary: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence complaint is confirmed based on the customers testimony as the clinical setting that could impact on the functionality of the device cannot be replicated in the laboratory.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Stent placement was performed to treat stenosis (from below duodenal bulb to second portion) due to pancreatic cancer.Evo-22-27-12-d/ c1570803 was advanced to the desired position and the user started deploying the stent from distal side.However, the tip of the stent did not expand even though there was no stenosis around the tip of the stent.The user deployed the stent until reaching point-of-no-return but the tip of the stent still did not expand, so the delivery system was removed from the body.The user attempted to deploy the tip of the stent outside the body and it expanded like flare shape.(this sentence means the tip of the stent expanded without problems outside the body.) another evo-22-27-12-d/ c1570803 was used but the same thing was happened, so the procedure was aborted.Stent placement with using competitor's stent or surgery will be performed.Fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of stent not expanding / opening post deployment'.No adverse effects to the patient have been reported as occurring.

• Brand Name: EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
• Common Device Name: MUM STENT, METALIC EXPANDABLE, DUODENAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8850289
• Report Number: 3001845648-2019-00382
• Device Sequence Number: 290053
• Product Code: MUM
• UDI-Device Identifier: 10827002480275
• UDI-Public: (01)10827002480275(17)201219(10)C1570803
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/04/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/19/2020
• Device Model Number: G48027
• Device Catalogue Number: EVO-22-27-12-D
• Device Lot Number: C1570803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/04/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2019
• Initial Report FDA Received Date: 08/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1