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

Model Number	H7493952824400
Medical Device Problem Codes	Bent (1059); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in a coronary artery.After a 145 guidezilla¿ guide extension catheter was advanced, a 4.00x24mm promus premier¿ drug-eluting stent was advanced to treat the lesion.However, the physician felt that the stent was getting caught in between the guidezilla¿ and the guide catheter.The device was then removed and the stent was found damaged.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.: the stent delivery system (sds) was returned for analysis.There were stent struts on the distal end of the stent that were bent and stretched.The undamaged outer diameter of the proximal end of the stent was measured and was within specification.The bumper tip of the device showed no signs of damage to the distal edge of the tip.The balloon cone profiles were reviewed and no issues were noted with the overall balloon profile.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination found multiple hypotube kinks.A visual and tactile examination found no issues with the profile.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 stent damage occurred.The target lesion was located in a coronary artery.After a 145 guidezilla¿ guide extension catheter was advanced, a 4.00x24mm promus premier¿ drug-eluting stent was advanced to treat the lesion.However, the physician felt that the stent was getting caught in between the guidezilla¿ and the guide catheter.The device was then removed and the stent was found damaged.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: 6136020
• Report Number: 2134265-2016-10596
• Device Sequence Number: 10915662
• Product Code: NIQ
• UDI-Device Identifier: 08714729844877
• UDI-Public: (01)08714729844877(17)20170817(10)18962686
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/03/2016

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: 08/17/2017
• Device Model Number: H7493952824400
• Device Catalogue Number: 39528-2440
• Device Lot Number: 18962686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/30/2016
• Supplement Report FDA Received Date: 01/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1