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

Model Number	9589
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is combination product.
Event or Problem Description
It was reported that stent damage occurred.A 3.50x38mm promus premier drug-eluting stent was selected for use to treat the lesion.However, before the device was inserted, it was noted that the stent had a frayed edge.The procedure was completed with another 3.50x38mm promus premier drug-eluting stent.No patient complications were reported.
Event or Problem Description
It was reported that stent damage occurred.A 3.50x38mm promus premier drug-eluting stent was selected for use to treat the lesion.However, before the device was inserted, it was noted that the stent had a frayed edge.The procedure was completed with another 3.50x38mm promus premier drug-eluting stent.No patient complications were reported.Device evaluated by manufacturer: a promus premier, us, mr 3.50 x 38 mm stent delivery system was returned for analysis.A visual examination of the stent found that the stent was damaged on the 7th and 9th proximal stent strut row with stent struts lifted.The undamaged stent outer diameter was measured and the result was within maximum crimped stent profile measurement.Stent damage most likely occurred during preparation when the stent protector was removed.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks along several locations of the hypotube shaft during analysis.This type of damage is consistent with excessive force that could have been applied to the delivery system.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.
Additional Manufacturer Narrative
Device is combination product.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/14/2018 07:31 am ct.The report number is being corrected from: 2134265-2018-64252 to: 2134265-2018-62996.

• 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: 8088748
• Report Number: 2134265-2018-62996
• Device Sequence Number: 1407210
• Product Code: NIQ
• UDI-Device Identifier: 08714729845034
• UDI-Public: 08714729845034
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 01/23/2019

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: 09/26/2019
• Device Model Number: 9589
• Device Catalogue Number: 9589
• Device Lot Number: 0021963188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 11/22/2018
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1