MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS ELITE; CORONARY DRUG-ELUTING STENT

Device Problems Material Deformation (2976); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2019

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that stent damage occured.The target lesion was located in a coronary artery.A 28 x 4.00 promus elite drug-eluting stent was advanced for treatment.However, when the stent was placed in the coronary, it was decided to move the stent proximally.The balloon was moved proximal but the stent seem to stretched away and was not moving in conjunction with the balloon.The stent had to be deployed out of the location that the physician intended so an additional stent was deployed in the target location to complete the procedure.The patient was considered not impacted in any way.

• Brand Name: PROMUS ELITE
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8932899
• MDR Text Key: 155667641
• Report Number: 2134265-2019-10059
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2019
• 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