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

Model Number	H7493952824270
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary vessel.A 2.75x24mm promus premier¿ stent was advanced to treat the lesion.However, the shaft broke upon delivery.The procedure was completed with another with same device.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr: promus premier, us, mr, 2.75 x 24mm stent delivery system (sds) was returned.A visual examination of the crimped stent found no issues with the crimped stent.There were no signs of damage; stretching or lifting of the stent struts.The stent showed no signs of movement and was set equidistant between the proximal and distal markerbands.The stent od (outer diameter) of the stent was measured and was within the maximum crimped stent specification indicating that there were no issues with the crimp stent profile.A visual and tactile examination found a hypotube break 263mm from the distal tip and multiple hypotube kinks along the full catheter length.A visual and tactile examination found multiple inner/outer kinks along the extrusion.This type of damage may have been caused by excessive forces exerted during withdrawal of the device.The bi-component bond showed no signs of damage or strain.A visual and tactile examination found no damage to the tip.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
It was reported that shaft break occurred.The target lesion was located in a coronary vessel.A 2.75x24mm promus premier stent was advanced to treat the lesion.However, the shaft broke upon delivery.The procedure was completed with another with same device.No patient complications were reported and the patient's status was fine.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6189328
• Report Number: 2134265-2016-11675
• Device Sequence Number: 16237451
• Product Code: NIQ
• UDI-Device Identifier: 08714729844846
• UDI-Public: (01)08714729844846(17)20170501(10)18608934
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2016

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: 05/01/2017
• Device Model Number: H7493952824270
• Device Catalogue Number: 39528-2427
• Device Lot Number: 18608934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2016
• Supplement Report FDA Received Date: 01/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1