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

Model Number 9553

Device Problems Difficult to Advance (2920); Material Deformation (2976)

Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/24/2021

Event Type  malfunction  

Event Description

It was reported that the stent damage occurred and the patient experienced pain.The target lesion was located in a coronary artery.A 32 x 3.50 promus premier drug-eluting stent was advanced for treatment, but could not be delivered to the lesion.After withdrawing the device, the stent strut was found to be lifted and deformed resulting in increased pain, procedure time, and risk to the patient.The procedure was not completed.

Event Description

It was reported that the stent damage occurred and the patient experienced pain.The target lesion was located in a coronary artery.A 32 x 3.50 promus premier drug-eluting stent was advanced for treatment, but could not be delivered to the lesion.After withdrawing the device, the stent strut was found to be lifted and deformed resulting in increased pain, procedure time, and risk to the patient.The procedure was not completed.It was further reported that the 95% stenosed target lesion was located in the right coronary artery.The procedure was completed with another of same device.There were no patient complications and the patient status was stable.

• Brand Name: PROMUS PREMIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12628448
• MDR Text Key: 276341128
• Report Number: 2134265-2021-12730
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2023
• Device Model Number: 9553
• Device Catalogue Number: 9553
• Device Lot Number: 0026861990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2021
• 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
• Patient Age: 76 YR
• Patient Sex: Male