MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY EXPRESS® LD ILIAC / BILIARY; STENT, ILIAC

Model Number	H74938046740750
Medical Device Problem Codes	Bent (1059); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Same case as mdr id 2134265-2017-09837.It was reported that stent damage occurred.The target lesion was located in the right iliac artery.A 7.0x40x75cm express® ld stent was advanced but failed to cross the lesion.The device was removed and was advanced again through the sheath.However, resistance was encountered upon advancing and it was noted that the stent struts was bent up.Subsequently, another 7.0x40x75cm express® ld stent was advanced for treatment; moreover, the stent slipped off from the balloon in the left iliac artery.The stent was pushed over the bifurcation and across the lesion in the right common iliac artery and was opened by a different balloon catheter.The procedure was completed.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr: a visual and microscopic examination was performed on the returned device.The device was returned with the stent fully attached to the delivery device.The sheath used during the procedure was not returned for analysis.The balloon was noted to be tightly folded and had not been subjected to positive pressure.A visual and microscopic examination identified no issues with the balloon material that could have contributed to the complaint incident.As part of the investigation the investigator successfully inflated the balloon with glycerol solution and deployed the stent, however resistance was encountered due to the movement of the stent distally along the balloon material.The device was returned with the stent still attached to the delivery system.The stent was noted to have moved distally along the balloon material.The distal markerband was covered by the stent.The proximal end of the stent was noted to be damaged.The stent struts were raised from the crimped stent.The investigator deployed the stent during analysis and a visual and microscopic examination was performed on the deployed stent.Due to the movement of the stent distally along the balloon material , the stent did not fully expand during deployment and the investigator had to manually remove the stent from the balloon material.No issues were noted with the stent that could have contributed to the complaint incident.No damage was observed to the tip of the device.A visual and tactile examination identified no damage or nay issues along the length of the device.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
Event or Problem Description
Same case as mdr id 2134265-2017-09837.It was reported that stent damage occurred.The target lesion was located in the right iliac artery.A 7.0x40x75cm express® ld stent was advanced but failed to cross the lesion.The device was removed and was advanced again through the sheath.However, resistance was encountered upon advancing and it was noted that the stent struts was bent up.Subsequently, another 7.0x40x75cm express® ld stent was advanced for treatment; moreover, the stent slipped off from the balloon in the left iliac artery.The stent was pushed over the bifurcation and across the lesion in the right common iliac artery and was opened by a different balloon catheter.The procedure was completed.No patient complications were reported and the patient's status was fine.

• Brand Name: EXPRESS® LD ILIAC / BILIARY
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6917795
• Report Number: 2134265-2017-09926
• Device Sequence Number: 1408976
• Product Code: NIO
• UDI-Device Identifier: 08714729392217
• UDI-Public: 08714729392217
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P090003
• 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,Followup
• Report Date (Section B): 09/18/2017

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: 09/12/2019
• Device Model Number: H74938046740750
• Device Catalogue Number: 38046-74075
• Device Lot Number: 19705077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Initial Date Received by Manufacturer: 09/18/2017
• Supplement Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 10/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1