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

Model Number 9554

Device Problem Failure to Advance (2524)

Patient Problems Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)

Event Date 07/28/2020

Event Type  malfunction  

Event Description

It was reported that cancelled procedure occurred.The target lesion was located in the coronary artery.A 38 mm x 3.50 mm promus premier stent was advanced to treat the lesion.However, during the procedure the stent could not cross the lesion.The procedure was not completed.No patient complications were reported and the patients status was stable.

Event Description

It was reported that cancelled procedure occurred.The 80-90 % stenosed target lesion was located in the coronary artery.A 38 mm x 3.50 mm promus premier stent was advanced to treat the lesion.However, during the procedure the stent could not cross the lesion.The procedure was not completed.No patient complications were reported and the patients status was stable.

Manufacturer Narrative

Patient code corrected.

• 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: 10443053
• MDR Text Key: 204047853
• Report Number: 2134265-2020-11509
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2021
• Device Model Number: 9554
• Device Catalogue Number: 9554
• Device Lot Number: 0024696959
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 65