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

Model Number 9583

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2018

Event Type  malfunction  

Manufacturer Narrative

Event date: no event date provided so first date of the month of the aware was used: (b)(6) 2018.Device is a combination product.

Event Description

It was reported that stent damage occurred.A 2.25x12mm promus premier stent was selected for treatment.However, the physician bent the hypotube to the stent.No patient complications were reported.

Event Description

It was reported that stent damage occurred.A 2.25x12mm promus premier stent was selected for treatment.However, the physician bent the hypotube to the stent.No patient complications were reported.Bsc would like to withdraw this event as the report was sent in error and does not meet the reporting criteria guidelines.The complaint is for a shaft kink with no allegation of stent damage.

Manufacturer Narrative

Event date: no event date provided so first date of the month of the aware was used - (b)(6) 2018.Device is a combination product.Correction: a correction was made to the "describe event or problem" section.Bsc would like to withdraw this event as the report was sent in error and does not meet the reporting criteria guidelines.The complaint is for a shaft kink with no allegation of stent damage.Product analysis further confirmed there was no sign of damage, stretching or lifting of the stent struts but did verify multiple severe hypotube kinks.

• Brand Name: PROMUS PREMIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8193610
• MDR Text Key: 131301770
• Report Number: 2134265-2018-64622
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729844648
• UDI-Public: 08714729844648
• Combination Product (y/n): N
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2019
• Device Model Number: 9583
• Device Catalogue Number: 9583
• Device Lot Number: 0022211916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Date Manufacturer Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR