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

Model Number H7493952838300

Device Problem Occlusion Within Device (1423)

Patient Problem Reocclusion (1985)

Event Date 06/04/2018

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: the device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).

Event Description

Same case as mdr id # 2134265-2018-06112.It was reported that in-stent restenosis (isr) occurred.In (b)(6) 2012 a 3.5x32mm promus element everolimus-eluting coronary stent system was implanted in the saphenous vein graft(svg) and in (b)(6) 2016 a 3.00x38mm promus premier¿ stent was implanted partially overlapping the promus element.In (b)(6) 2018 the stents were noted to have restenosed.A 10mmx3.00mm wolverine¿ coronary cutting balloon® monorail® was advanced in an attempt to dilate and failed to cross the isr.The procedure was completed with a different device.No further patient complications were reported.

• Brand Name: PROMUS PREMIER¿
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7645708
• MDR Text Key: 112582405
• Report Number: 2134265-2018-05797
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729845027
• UDI-Public: 08714729845027
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2017
• Device Model Number: H7493952838300
• Device Catalogue Number: 39528-3830
• Device Lot Number: 19316896
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention