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

Model Number	H74938047840130
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that stent dislodgment occurred.The target lesion is located in the iliac vessel.A 8.0x40x135 cm express® ld iliac / biliary stent was advanced to treat the lesion.However, after inflating the balloon, it was noticed that there was no stent being implanted.It was then found out that the stent was dislodged in the hoop during preparation and never went inside the patient's body.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: the delivery system was returned for analysis.A visual and microscopic examination was performed on the returned device.The stent was completely detached from the delivery system and was returned in a plastic container.A visual and microscopic examination was performed on the returned delivery system.An examination of the balloon identified that the balloon had been inflated and there was a build-up of contrast media present inside the balloon.An examination of the stent found that the stent was compressed at one end.The stent did not appear to have been deployed.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 investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).
Event or Problem Description
It was reported that stent dislodgment occurred.The target lesion is located in the iliac vessel.A 8.0x40x135 cm express ld iliac/biliary stent was advanced to treat the lesion.However, after inflating the balloon, it was noticed that there was no stent being implanted.It was then found out that the stent was dislodged in the hoop during preparation and never went inside the patient's body.The procedure was completed with another of the same device.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: 7579246
• Report Number: 2134265-2018-05068
• Device Sequence Number: 2527197
• Product Code: NIO
• UDI-Device Identifier: 08714729392477
• UDI-Public: 08714729392477
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 05/17/2018

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: 02/05/2021
• Device Model Number: H74938047840130
• Device Catalogue Number: 38047-84013
• Device Lot Number: 21706515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 07/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1