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

Model Number 9584

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 09/16/2018

Event Type  malfunction  

Event Description

It was reported that mislabeling occurred.During unpacking of an promus premier stent, it was noticed that the size on the package (3.5mmx16mm) and the device inside (3.5mmx20mm) did not match.The device was not used and a new promus premier stent was used to complete the procedure.No patient complications were reported.

Event Description

It was reported that mislabeling occurred.During unpacking of an promus premier stent, it was noticed that the size on the package (3.5mmx16mm) and the device inside (3.5mmx20mm) did not match.The device was not used and a new promus premier stent was used to complete the procedure.No patient complications were reported.The device was returned in an opened outer box.The blue tab seal was not intact.The outer box packaging was labelled as promus premier 3.50 x 16 mm batch# 22290101.A foil pouch with seal intact labelled promus premier 3.50 x 20 mm batch# 21942673 was inside the opened box packaging labelled promus premier 3.50 x 16 mm batch# 22290101.The foil pouch opened by analyst and the inner tyvek pouch labelled promus premier 3.50 x 20 mm batch# 21942673 was inside with seal intact lot# 21932653-019.No other issues were identified during product analysis.Analysis determined that the condition of the returned device was consistent with the complaint incident as the label on the outer box packaging was different from the label on the actual device inside the box.The outer box packaging was returned open with the blue tab seal broken.A general action was assigned to the secondary pack product unit for manufacturing information and a response was received which confirmed that controls are in place during the manufacturing process to prevent incorrect labelling and that the two batches were manufactured and packaged on different dates.This is not a manufacturing issue, the incident cannot be confirmed.

• 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: 7957814
• MDR Text Key: 123490971
• Report Number: 2134265-2018-61713
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729844747
• UDI-Public: 08714729844747
• 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: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2019
• Device Model Number: 9584
• Device Catalogue Number: 9584
• Device Lot Number: 0022290101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Initial Date Manufacturer Received: 09/17/2018
• Initial Date FDA Received: 10/11/2018
• Supplement Dates Manufacturer Received: 11/15/2018
• Supplement Dates FDA Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1