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

Model Number 10664

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/23/2020

Event Type  Injury  

Event Description

It was reported that stent fracture occurred.Vascular access was obtained via the right femoral artery.The 80% stenosed, 18mmx3.5mm, concentric, de novo target lesion was located in the non-tortuous and non-calcified right coronary artery.After engaging the lesion with a jr 3.5 guide catheter and placing a non-boston scientific (bsc) wire, a 20x3.50mm promus premier select drug-eluting stent was advanced to treat the lesion.However, post-deployment, the physician noticed the stent fractured at the mid to distal segment.Post-dilatation was performed with a 3.5x10 non-bsc balloon and a 3.5x18mm non-bsc stent was deployed to overlap the distal segment.The procedure was completed with another of the same device.There were no patient complications reported and the outcome was good.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11155088
• MDR Text Key: 226270914
• Report Number: 2134265-2021-00159
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2021
• Device Model Number: 10664
• Device Catalogue Number: 10664
• Device Lot Number: 0024238703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2019
• 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
• Treatment: WIRE: BMW
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR