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

Model Number 10662

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Obstruction/Occlusion (2422)

Event Date 12/09/2022

Event Type  Death  

Event Description

It was reported that the patient died.The target lesion was located in a proximal to mid vessel.Two promus premier select stents, a 3.50 x 12mm and a 3.00 x 12mm, were implanted to treat the lesion without issue.Post procedure the patient was under observation and subsequently died the next day due to blockage in the artery.

Event Description

It was reported that the patient died.The target lesion was located in a proximal to mid vessel.Two promus premier select stents, a 3.50 x 12mm and a 3.00 x 12mm, were implanted to treat the lesion without issue.Post procedure the patient was under observation and subsequently died the next day due to blockage in the artery.It was further reported that the 80% target lesion, with a moderately angulation, was located in a severely calcified, moderately tortuous lesion.There were no issues with stent deployment.In physician opinion, death was related due to other post procedural issues and there was no direct relationship found between promus premier select and death.

• Brand Name: PROMUS PREMIER SELECT
• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16014653
• MDR Text Key: 305803537
• Report Number: 2124215-2022-53603
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10662
• Device Catalogue Number: 10662
• Device Lot Number: 0029562507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2022
• 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): Death
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 55 KG
• Patient Race: Asian