MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS LD ILIAC / BILIARY; STENT, ILIAC

Model Number	20226
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 10.0 x 40 x 135 cm express ld stent was deployed.Upon removal, the balloon became caught in the sheath and the shaft broke.The device was removed and no further complications were reported.
Event or Problem Description
It was reported that shaft break occurred.A 10.0x40x135 cm express ld stent was deployed.Upon removal, the balloon became caught in the sheath and the shaft broke.The device was removed and no further complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: an express ld stent 10x40x135 was received for analysis.The recommended introducer sheath size for this express ld device as per express specification is a 7fr.The distal section of the device was received inside the customer's 7fr sheath.For investigation purposes the investigator removed the device section from the customer's sheath.A visual examination identified that the balloon had been subjected to positive pressure.Blood was identified inside the balloon which is evidence of a device leak.The balloon could not be inflated due to a shaft break.No issues were noted with balloon that could potentially have contributed to the complaint incident.A visual and microscopic examination found the stent to have been deployed from the device.The stent was not returned for analysis as it had been implanted inside the patient.A visual and tactile examination found the shaft of the device to be detached at the proximal of the balloon sleeve.This type of damage is consistent with excessive tensile force being applied to the device.No other issues were identified with the shaft.A visual and microscopic examination of the device identified no issues with the markerbands or tip that could have contributed to the complaint incident.No other issues were identified during the product analysis.

• Brand Name: EXPRESS LD ILIAC / BILIARY
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10505002
• Report Number: 2134265-2020-12307
• Device Sequence Number: 16902319
• Product Code: NIO
• UDI-Device Identifier: 08714729392385
• UDI-Public: 08714729392385
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K133110
• 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): 10/15/2020

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: 11/30/2020
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0021457017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 10/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1