MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT RP ENDOPROSTHESIS; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number	26265
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the stent was deformed.A unistep plus wallstent was selected for use for a biliary tract stent implantation in the bile ducts.The stent reached the lesion and deployed for about 1cm when the physician noticed the stent was deformed.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Patient's weight is 65.5 kg.Device evaluated by mfr.: a visual and microscopic examination was performed on the returned wallstent device.A visual and tactile examination identified multiple severe kinks along the catheter of the device.These kinks extended from the outer sheath down into the inner shaft.This type of damage is consistent with excessive force being applied to the delivery system.No issues were noted with the catheter that could have contributed to the damage identified.The device was received with the stent partially deployed and approximately 6mm of stent was noted to be protruding form under the outer sheath.The struts located on this distal protruding section of stent were noted to be damaged.The investigator deployed the stent however resistance was encountered due to the catheter kinks and the distal stent damage.A visual and microscopic examination identified damage to the mid section of the stent, however the majority of the damage was located at the distal end of the stent.The damage observed in the mid section of the stent may have been caused by the severe catheter kinks identified on the inner and outer shaft.The damaged distal section of stent most likely prevented full reconstrainment of the stent and as this section of the stent was unprotected this may have resulted in the stent damage increasing during removal from the patient or during shipping.No issues were noted with the stent that could have contributed to the damage identified.A visual and microscopic examination found no damage or any issues with the tip, stent cups or stent holder of the device that may have potentially contributed to the complaint incident.No further issues were identified during product analysis.
Event or Problem Description
It was reported that the stent was deformed.A unistep plus wallstent was selected for use for a biliary tract stent implantation in the bile ducts.The stent reached the lesion and deployed for about 1cm when the physician noticed the stent was deformed.The procedure was completed with another of the same device.There were no patient complications reported.It was further reported the stent was fully reconstrained when removed.

• Brand Name: WALLSTENT RP ENDOPROSTHESIS
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8165068
• Report Number: 2134265-2018-64111
• Device Sequence Number: 2179035
• Product Code: FGE
• UDI-Device Identifier: 08714729406372
• UDI-Public: 08714729406372
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K992510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2019

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: 12/07/2018
• Device Model Number: 26265
• Device Catalogue Number: 26265
• Device Lot Number: 0020050959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 12/14/2018
• Supplement Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR