MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY ION¿; CORONARY DRUG-ELUTING STENT

Model Number	H7493902432250
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).Device evaluated by mfr.: stent delivery system (sds) was returned for analysis.A visual examination of the stent found that on distal rows 15 and 16, stent struts were lifted and twisted.The bumper tip of the device showed no signs of damage.A visual and tactile examination found several kinks across the length of the hypotube.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination of the outer and mid-shaft section found no issues with the extrusion.The bi-component bond showed no signs of damage or strain.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
Reportable based on device analysis completed on 17-oct-2016.It was reported that crossing difficulties were encountered.The target lesion was located in the highly calcified left anterior descending artery.A 32mm x 2.50mm ion" drug-eluting stent was advanced but failed to cross the lesion.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed stent damage.

• Brand Name: ION¿
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6097568
• Report Number: 2134265-2016-09857
• Device Sequence Number: 294326
• Product Code: NIQ
• UDI-Device Identifier: 08714729810742
• UDI-Public: (01)08714729810742(17)20161022(10)18035054
• Combination Product (Y/N): N
• PMA/510(K) Number: P100023
• 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): 10/17/2016

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: 10/22/2016
• Device Model Number: H7493902432250
• Device Catalogue Number: 39024-3225
• Device Lot Number: 18035054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2016
• Initial Report FDA Received Date: 11/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR