MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLSTENT¿ ENTERAL ENDOPROSTHESIS; STENT, COLONIC, METALIC, EXPANDABLE

Model Number	M00565590
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).A wallstent enteral uncovered stent and delivery system were returned for analysis.The stent was received not deployed.Visual analysis of the returned device identified uncrossed and kinked stent wires at one end of the stent.The blue outer sheath was stretched and bent.The clear outer sheath at the distal end was also bent.Functional evaluation revealed that it was not possible to deploy the stent using the delivery system as received and there was a significant resistance encountered during attempted deployment.However, the stent was deployed by cutting the outer sheath and pulling the tip distally.No other issues were noted with the stent and delivery system.The damages noted with the returned device were consistent with the application of excessive force during used.Taking all available information into consideration, the investigation concluded that the observed failures and the reported event were likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause is operational context.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.A search of the complaint database confirmed that no other similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a wallstent enteral uncovered stent was to be used to treat an intestinal obstruction due to malignant stenosis during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was tight.According to the complainant, during procedure, the stent failed to deploy when it reached the stenosis along the guidewire in the intestinal tract.The stent was removed from the patient fully covered by the outer sheath.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: this event has been deemed an mdr-reportable event based on investigation results which revealed uncrossed and kinked stent wires at the distal end.

• Brand Name: WALLSTENT¿ ENTERAL ENDOPROSTHESIS
• Common Device Name: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7890809
• Report Number: 3005099803-2018-02607
• Device Sequence Number: 1908669
• Product Code: MQR
• UDI-Device Identifier: 08714729285083
• UDI-Public: 08714729285083
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K000281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/28/2018

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: 09/15/2018
• Device Model Number: M00565590
• Device Catalogue Number: 6559
• Device Lot Number: 0019721714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1