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

Model Number 10677

Device Problem Fracture (1260)

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

Event Date 03/25/2024

Event Type  Injury  

Event Description

It was reported that stent damage post deployment occurred.Vascular access was obtained via the right radial artery.The 80% stenosed, 22mm long, concentric, de novo target lesion was located in the severely tortuous and non-calcified left main artery.Following pre-dilation with a 2.50 x 20 mm non-boston scientific (non-bsc) balloon, there was 20% residual stenosis.The 3.50 x 38 mm promus elite stent was deployed to treat the target lesion, however, during post-dilation with a non-bsc nc balloon, the proximal end of the stent was fractured.A 4.00 x 12 mm non-bsc stent was deployed inside the promus elite.There were no patient complications reported and the patient condition following the procedure was stable.

Manufacturer Narrative

E1 initial reporter phone: (b)(6).

• 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: 19084132
• MDR Text Key: 339876925
• Report Number: 2124215-2024-21059
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: EG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10677
• Device Catalogue Number: 10677
• Device Lot Number: 0029825364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2022
• 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
• Treatment: BMW GUIDEWIRE; NC EUPHORA BALLOON; XB GUIDE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male