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

Model Number	20226
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event - 18 years or older.Device evaluated by mfr.: the device was returned for analysis.An examination of the returned device identified that the stent was crimped on the balloon.An examination of the stent found that the stent was pulled approximately 2mm distally on the balloon.The distal edge of the stent was positioned over the distal markerband.Two of the distal struts were lifted and bent back distally.This type of damage is consistent with the stent getting caught during withdrawal.No kinks were noted along the shaft.The device was attached to an encore inflation unit and the balloon was inflated to its rated burst pressure with no resistance noted.The inflation atmospheres were verified on the inflation device before and after use with a calibrated pressure gauge.The stent expanded on the balloon.The deployed stent was examined and part from the distal edge struts which had been lifted on the balloon, there was no other damage present along the stent.A vacuum was pulled and the balloon deflated fully with no resistance noted.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 25-jul-2019.It was reported that stent deployment failure occurred.The target lesion was located in the iliac artery.A 8.0x60x135cm express ld iliac stent was advanced for treatment.However, it was noted that the device failed to deploy.The procedure was completed with another of the same device.No patient complications were reported and patient's status was stable.However, returned device analysis revealed that the stent moved on the balloon and stent damage.

• 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: 8865727
• Report Number: 2134265-2019-09289
• Device Sequence Number: 11311758
• Product Code: NIO
• UDI-Device Identifier: 08714729392484
• UDI-Public: 08714729392484
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K133110
• 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): 08/06/2019

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: 07/05/2019
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0019444207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 08/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1