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

Model Number	H7493952816250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Paralysis (1997); Discomfort (2330); Diaphoresis (2452)
Date of Event	06/12/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Same case as mdr id # 2134265-2018-06025.It was reported that patient discomfort and complications occurred.Vascular access was obtained via the radial artery.A promus premier¿ stent was implanted the obtuse margin.After the procedure, upon transportation back to the patient's room, the patient became diaphoretic and was brought back to the catheterization lab.The previously implanted stent was widely patent, however, there was a focal lesion in the right coronary artery (rca) that had been undetected.A promus premier¿ stent was then placed in the rca.After the second stent was implanted, the patient's arm was "frozen" and severely uncomfortable.The patient's current status is okay.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7682078
• Report Number: 2134265-2018-06026
• Device Sequence Number: 19161575
• Product Code: NIQ
• UDI-Device Identifier: 08714729844716
• UDI-Public: 08714729844716
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/15/2018

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: 07/11/2018
• Device Model Number: H7493952816250
• Device Catalogue Number: 39528-1625
• Device Lot Number: 20181488
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 07/12/2018
• 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: Other