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

Model Number 10677

Device Problems Material Rupture (1546); Failure to Advance (2524); Activation Failure (3270)

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

Event Date 02/15/2022

Event Type  malfunction  

Event Description

It was reported that balloon rupture and partial stent deployment occurred.The 60% stenosed target lesion was located in the mildly tortuous and moderately calcified anterior descending artery.Angioplasty was performed with a 2.5 x 15mm wolverine cutting balloon.A 38 x 3.00 promus elite stent was advanced for treatment.However, the device failed to cross the proximal part of the lesion.A guidezilla extension catheter was used to allow the passage of the stent.During deployment of the stent, the balloon burst on the initial inflation at 12 atmospheres and the stent was released within the artery without adequate apposition.The stent was retrieved and the entire rail system removed without complication.The procedure was completed with a 3.0 x 38mm non-boston scientific stent.No patient complications were reported, and the patient status was stable.

Event Description

It was reported that balloon rupture and partial stent deployment occurred.The 60% stenosed target lesion was located in the mildly tortuous and moderately calcified anterior descending artery.Angioplasty was performed with a 2.5 x 15mm wolverine cutting balloon.A 38 x 3.00 promus elite stent was advanced for treatment.However, the device failed to cross the proximal part of the lesion.A guidezilla extension catheter was used to allow the passage of the stent.During deployment of the stent, the balloon burst on the initial inflation at 12 atmospheres and the stent was released within the artery without adequate apposition.The stent was retrieved and the entire rail system removed without complication.The procedure was completed with a 3.0 x 38mm non-boston scientific stent.No patient complications were reported, and the patient status was stable.

Manufacturer Narrative

A review of the image provided by the site confirms the balloon damage/rupture.An accumulation of fluid (haziness) is visible proximally to the positioned stent and also running almost the entire length of the stent.No clear stent expansion was noted in the image provided.

• Brand Name: PROMUS ELITE
• 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: 13588862
• MDR Text Key: 286062164
• Report Number: 2134265-2022-01951
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2023
• Device Model Number: 10677
• Device Catalogue Number: 10677
• Device Lot Number: 0027278253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2021
• 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 Sex: Male