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

Model Number H7493952820400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Paralysis (1997); Discomfort (2330); Diaphoresis (2452)

Event Date 06/12/2018

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 #2134265-2018-06026.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¿
• 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: 7682085
• MDR Text Key: 113786683
• Report Number: 2134265-2018-06025
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729844815
• UDI-Public: 08714729844815
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2019
• Device Model Number: H7493952820400
• Device Catalogue Number: 39528-2040
• Device Lot Number: 0021597080
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2018
• 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): Other