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

Model Number	H7493952812220
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Occlusion (1984)
Date of Event	02/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: the complaint device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).
Event or Problem Description
Same case as mdr case # 2134265-2017-01459 and 2134265-2017-01571.It was reported that acute stent thrombosis and chest pain occurred.In (b)(6) 2017, 2 target lesions were identified.The target lesion#1 was located in the second obtuse marginal.Target lesion#2 was located in the mid left anterior descending artery (mlad).2000 units of heparin was given.Target lesion#1 was then treated with 2.50 x 12 synergy ii drug-eluting stent (des) and 2.25x12mm promus premier¿ des.Target lesion#2 was treated with a 2.75x32mm promus premier¿ des and the procedure was completed.The following day, the patient presented due to chest pain and electrocardiogram was performed.It was then noted that the portion of the small circumflex artery was occluded.4000 units of heparin was given and a 2.25x15mm emerge balloon catheter was then advanced and dilated the occluded area for 6 inflations.The patient's status was stable and the patient was then discharged.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6385573
• Report Number: 2134265-2017-01570
• Device Sequence Number: 11006716
• Product Code: NIQ
• UDI-Device Identifier: 08714729844648
• UDI-Public: (01)08714729844648(17)20180508(10)19977480
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 02/13/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/08/2018
• Device Model Number: H7493952812220
• Device Catalogue Number: 39528-1222
• Device Lot Number: 19977480
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2017
• Initial Report FDA Received Date: 03/07/2017
• 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