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

Model Number	H7493925216250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	06/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product. the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. the investigation conclusion is user / use error as there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user.  (b)(4).
Event or Problem Description
Same case as mdr id: 2134265-2018-07108, 2134265-2018-07109, 2134265-2018-07110.It was reported that patient ¿coded¿.The 90% stenosed target lesion was located in the left anterior descending (lad) artery.The patient also had a chronic total occlusion in the right lad as well as significant disease in the circumflex and in the obtuse marginals.There were a total of 4 bsc stents deployed in the lad and only one was expired which was the 16 x 2.50 promus premier¿ stent.The 3 other stents were one promus otw and 2 synergy mr stents.The expired stent was discovered after the case, when the devices used were being consolidated.The procedure was completed and the patient was fine.However, 3 days post-procedure, the patient coded.A temporary pacemaker was implanted to control the patient's heart rhythm.No further patient complications were reported and the patient was recovering.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7710617
• Report Number: 2134265-2018-06359
• Device Sequence Number: 2580288
• Product Code: NIQ
• UDI-Device Identifier: 08714729828860
• UDI-Public: 08714729828860
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/25/2018

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: 04/16/2018
• Device Model Number: H7493925216250
• Device Catalogue Number: 39252-1625
• Device Lot Number: 19885264
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 07/23/2018
• 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: Hospitalization; Required Intervention