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

Model Number	H7493952828300
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: fg,promus premier,us, mr 3.00x28mm stent delivery system (sds) was returned for analysis without a stent.No stent returned.Stent separated from sds.The balloon wings were out of there folded position and were slightly misshapen.A visual and tactile examination found multiple hypotube kinks.A visual and tactile examination of the shaft polymer extrusion revealed a shaft polymer extrusion kink 63mm proximal to the distal end of the tip.A visual and microscopic 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 cause of the reported difficulties may be due to interaction with another device.(b)(4).
Event or Problem Description
Reportable based on device analysis completed on 26-apr-2017.It was reported that catheter advancing difficulties were encountered.  the target lesion was located in a coronary artery.A 3.00x28mm promus premier¿ drug-eluting stent was advanced to treat the lesion.However, the device was unable to advance through a non-bsc guide extension catheter.The device was removed and 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 detachment/separation.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6556914
• Report Number: 2134265-2017-04609
• Device Sequence Number: 13669855
• Product Code: NIQ
• UDI-Device Identifier: 08714729844914
• UDI-Public: (01)08714729844914(17)20171218(10)19430341
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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
• Report Date (Section B): 04/26/2017

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: 12/18/2017
• Device Model Number: H7493952828300
• Device Catalogue Number: 39528-2830
• Device Lot Number: 19430341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2017
• Initial Report FDA Received Date: 05/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDELINER GUIDE EXTENSION CATHETER