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

Model Number 10674

Device Problem Fracture (1260)

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

Event Date 03/19/2024

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address 1:(b)(6).

Event Description

It was reported that stent fracture occurred.During preparation, a 24 x 3.00 promus elite drug-eluting stent was selected for used.However, the stent in its original packaging was observed to be divided into two sections.The device was not used, and the procedure was completed using an alternate device.No patient complications were reported.

Event Description

It was reported that stent fracture occurred.During preparation, a 24 x 3.00 promus elite drug-eluting stent was selected for used.However, the stent in its original packaging was observed to be divided into two sections.The device was not used, and the procedure was completed using an alternate device.No patient complications were reported.

Manufacturer Narrative

E1: initial reporter address 1: (b)(6).The device was not returned for analysis; therefore, a technical analysis could not be performed.However, a photo attached to the complaint record shows a break in the shaft polymer extrusion at the port exchange.

• Brand Name: PROMUS ELITE
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19102374
• MDR Text Key: 340464230
• Report Number: 2124215-2024-18982
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10674
• Device Catalogue Number: 10674
• Device Lot Number: 0031371398
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2023
• 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