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

Model Number	9583
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date: no event date provided so first date of the month of the aware was used: (b)(6) 2018.Device is a combination product.
Event or Problem Description
It was reported that stent damage occurred.A 2.25x12mm promus premier stent was selected for treatment.However, the physician bent the hypotube to the stent.No patient complications were reported.
Event or Problem Description
It was reported that stent damage occurred.A 2.25x12mm promus premier stent was selected for treatment.However, the physician bent the hypotube to the stent.No patient complications were reported.Bsc would like to withdraw this event as the report was sent in error and does not meet the reporting criteria guidelines.The complaint is for a shaft kink with no allegation of stent damage.
Additional Manufacturer Narrative
Event date: no event date provided so first date of the month of the aware was used - (b)(6) 2018.Device is a combination product.Correction: a correction was made to the "describe event or problem" section.Bsc would like to withdraw this event as the report was sent in error and does not meet the reporting criteria guidelines.The complaint is for a shaft kink with no allegation of stent damage.Product analysis further confirmed there was no sign of damage, stretching or lifting of the stent struts but did verify multiple severe hypotube kinks.

• Brand Name: PROMUS PREMIER
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8193610
• Report Number: 2134265-2018-64622
• Device Sequence Number: 2639958
• Product Code: NIQ
• UDI-Device Identifier: 08714729844648
• UDI-Public: 08714729844648
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/13/2019

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: 11/20/2019
• Device Model Number: 9583
• Device Catalogue Number: 9583
• Device Lot Number: 0022211916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 12/24/2018
• Supplement Report FDA Received Date: 02/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR