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

Model Number	9584
Medical Device Problem Codes	Failure to Advance (2524); Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: fg,promus premier,us, mr 3.00x16mm stent delivery system was returned for analysis.An examination (visual and via scope) of the crimped stent found stent damage.The damage was noted to the 3 most proximal stent strut rows with struts lifted and pulled back distally.Struts of most distal stent stut row lifted and flared outwards.The stent showed no signs of movement and was set between the proximal and distal marker bands.The crimped stent outer diameter was within max crimped stent profile measurement.The balloon was 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 tactile examination of the hypotube found multiple kinks.A visual and tactile examination of the shaft polymer extrusion found no issues.An examination (visual and via scope) found tip damage.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 15may2019.It was reported that crossing difficulties were encountered and the balloon as bulging at the ends of the stent.A 3.00x16mm promus premier drug-eluting stent was advanced but failed to cross the lesion.The device was removed after several attempts and upon inspection, it was noted that the balloon was bulging at the end of the stent.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed stent damage.

• 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: 8682864
• Report Number: 2134265-2019-06624
• Device Sequence Number: 16708486
• Product Code: NIQ
• UDI-Device Identifier: 08714729844730
• UDI-Public: 08714729844730
• Combination Product (Y/N): N
• Initial Reporter Country: TD
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/10/2019

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: 05/24/2020
• Device Model Number: 9584
• Device Catalogue Number: 9584
• Device Lot Number: 0023026810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 06/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR