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

Model Number	H7493952838270
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Chest Pain (1776); Thrombosis (2100)
Date of Event	12/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is combination product.It is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that the implanted stent was undersized and chest pain and stent thrombosis occurred.The target lesion was located in the proximal left anterior descending artery (lad).The 2.75x38mm promus premier stent was implanted and post-dilated to finish the procedure.The patient left the cath lab.Within two hours the patient had chest pain and was brought back to the cath lab.The stent had thrombosed and it was noted that the stent was undersized.The stent was dilated with a 4.0 non-compliant balloon and a 4.0x24mm promus premier was implanted to complete the procedure.No further patient complications were reported and the patient was fine.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7173553
• Report Number: 2134265-2017-13242
• Device Sequence Number: 13746571
• Product Code: NIQ
• UDI-Device Identifier: 08714729845010
• UDI-Public: 08714729845010
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/05/2019
• Device Model Number: H7493952838270
• Device Catalogue Number: 39528-3827
• Device Lot Number: 21024046
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2017
• Initial Report FDA Received Date: 01/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention