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

Model Number 10674

Device Problem Device Damaged by Another Device (2915)

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

Event Date 03/11/2024

Event Type  Injury  

Manufacturer Narrative

The reported device was not returned for analysis.A cine image was provided of the deployed stent.A review of the image available confirms the alleged stent deformation.The image shows a stent deployed on a wire with what appears to be the mid to proximal stent region damaged.

Event Description

It was reported that stent damage post deployment with secondary device interaction occurred which required additional intervention.The target lesion was located in the left anterior descending artery.A 24 x 2.50mm promus elite mr drug eluting stent (des) was advanced for treatment and was deployed at 12 atmospheres.However, the proximal part of the stent was deformed.The struts and the mid part of the balloon shaft were compressed when attempting to post dilate with a 2.50x8mm nc balloon catheter.Another des was deployed to cover the deformed part and missed lesion due to stent struts being compressed.The procedure was completed and there were no patient complications reported.

• 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: 19041630
• MDR Text Key: 339380271
• Report Number: 2124215-2024-18185
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10674
• Device Catalogue Number: 10674
• Device Lot Number: 0030743734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2022
• 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
• Patient Sex: Female
• Patient Race: Asian