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

Model Number 10663

Device Problem Activation Failure (3270)

Patient Problem Ischemia (1942)

Event Date 03/29/2022

Event Type  Injury  

Event Description

It was reported that inadequate apposition occurred.The 85% stenosed target lesion was located in the non-tortuous and severely calcified left anterior descending artery.Following predilation with a 2.00 x 8mm semi compliant balloon, the 2.50 x 16mm promus premier select drug eluting stent was implanted to treat the target lesion.The stent did not open completely with the stent balloon so an attempt was made to inflate the stent with a 2.75 x 12mm non compliant balloon at 22 atmospheres.The stent still did not open completely and was not well apposed.The desired timi 3 flow was not achieved and the patient was sent for coronary artery bypass graft surgery for complete revascularization.

• 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 johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14121444
• MDR Text Key: 289422331
• Report Number: 2134265-2022-04166
• 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: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2023
• Device Model Number: 10663
• Device Catalogue Number: 10663
• Device Lot Number: 0027864224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2021
• 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): Required Intervention