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

Model Number 10668

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

Patient Problem Vascular Dissection (3160)

Event Date 01/22/2022

Event Type  Injury  

Event Description

It was reported that vessel dissection occurred.The patient was diagnosed with small vessel disease.The target lesion was located in the left anterior descending artery.Following pre-dilatation, a 32 x 3.50 promus premier select stent was advanced to treat the lesion.However, it was observed under fluoroscopy that the stent was shorter in length and would not be able to cover the entire lesion.The 3.50 x 32 mm promus premier select stent was removed and a 38 x 4.00 promus premier select stent was deployed instead.However, post deployment, a distal stent edge dissection was observed.Subsequently, a 38 x 2.50 promus premier select stent was deployed to cover the dissection and the procedure was completed.No further patient complications were reported.

• 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: 16030392
• MDR Text Key: 305973649
• Report Number: 2134265-2022-08968
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2022
• Device Model Number: 10668
• Device Catalogue Number: 10668
• Device Lot Number: 0026314677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Race: Asian