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

Model Number 9551

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/05/2024

Event Type  malfunction  

Event Description

It was reported that a stent fracture occurred.The target lesion was located in the left circumflex artery.A 24 x 2.50 promus premier drug eluting stent was advanced for treatment.However, during crossing the lesion, the stent fractured at the first diagonal (dg1).The device was removed, and the procedure was completed with another 2.75 x 24mm promus premier stent.There were no patient complications reported.And the patient was fully recovered.

Manufacturer Narrative

The promus premier ous mr 24 x 2.50mm stent delivery system was returned for analysis.Visual and tactile inspection revealed no issues with the shaft, the outer/mid-shaft sections or the inner lumen of the device.Visual and microscopic inspection showed the stent struts were pulled from the mid-section over the distal balloon cone and bumper tip.Microscopic inspection showed no issues with the balloon or bumper tip.The undamaged stent od (outer diameter) was measured within max crimped stent profile measurement.

Event Description

It was reported that a stent fracture occurred.The target lesion was located in the left circumflex artery.A 24 x 2.50 promus premier drug eluting stent was advanced for treatment.However, while crossing the lesion, the stent fractured at the first diagonal (dg1).The device was removed, and the procedure was completed with another 2.75 x 24mm promus premier stent.There were no patient complications reported.And the patient was fully recovered.

• Brand Name: PROMUS PREMIER
• 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: 18769143
• MDR Text Key: 336546569
• Report Number: 2124215-2024-10901
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: TH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9551
• Device Catalogue Number: 9551
• Device Lot Number: 0031624162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2023
• 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