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

Model Number 10664

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2021

Event Type  Injury  

Manufacturer Narrative

Age at time of event: patient is 18 years or older.

Event Description

It was reported that stent fracture occurred.The 85% stenosed target lesion with no significant bend was located in a bifurcated region of the mildly tortuous and mildly calcified left anterior descending artery.Following pre-dilatation with a 3.50 x 12mm semi compliant balloon, a 20 x 3.50 promus premier select drug-eluting stent was used to treat the lesion.However, after post-dilatation with 4.0 x 6 non compliant balloon catheter, a fracture on the proximal area of the stent was observed.The physician used a different device to cover the fractured portion of the stent.No patient complications were reported and the patient status was stable.

• 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: 11625608
• MDR Text Key: 244162647
• Report Number: 2134265-2021-03724
• 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: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2022
• Device Model Number: 10664
• Device Catalogue Number: 10664
• Device Lot Number: 0025642904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2020
• 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: BALLOON CATHETER USED: 3.5X12 SC AND 4.0X6 NC
• Patient Outcome(s): Required Intervention