MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS PREMIER¿; STENT, CORONARY, DRUG-ELUTING

Model Number	H7493952838400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.  device evaluated by mfr: promus premier us mr 4.00 x 38mm stent delivery system was returned for analysis.The distal portion of the device was not returned.This includes the wire exchange port, shaft polymer extrusion, balloon, stent and tip.The stent was not returned for analysis as the distal portion of the device was detached and not returned.The manufacturing crimp data for this device was reviewed and there were no anomalies noted.The maximum stent profile was within max crimped stent profile measurement.A visual and tactile examination of the device found multiple hypotube kinks.An examination of the shaft polymer extrusion revealed a midshaft break 1070 mm distal from the distal end of the strain relief exposing the core wire.The portion of the device distal of the break site was not returned.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 not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2018.A 4.00x38mm promus premier¿ drug-eluting stent was received with no issue reported.However, upon review of this device, mid-shaft broken and stent detachment/separation occurred.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7596017
• Report Number: 2134265-2018-05171
• Device Sequence Number: 1201288
• Product Code: NIQ
• UDI-Device Identifier: 08714729845041
• UDI-Public: 08714729845041
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/22/2018

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: 03/12/2019
• Device Model Number: H7493952838400
• Device Catalogue Number: 39528-3840
• Device Lot Number: 0021152296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 06/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1