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

Model Number 10677

Device Problem Fracture (1260)

Patient Problem Perforation of Vessels (2135)

Event Date 05/24/2020

Event Type  Injury  

Manufacturer Narrative

Device is combination product.

Event Description

It was reported that stent fracture and vessel trauma occurred.The patient presented with coronary artery disease for percutaneous transluminal coronary angioplasty (ptca).The target lesion was located in the left main to left anterior descending artery and was treated with placement of a 38 x 3.0mm promus elite drug-eluting stent.When the physician attempted a proximal optimization technique in the left main with a 8 x 4.0mm balloon, the stent was fractured and vessel trauma occurred.A 9 x 4.0mm stent was implanted to complete the procedure without further device or patient issues.

• 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: 10139914
• MDR Text Key: 194699924
• Report Number: 2134265-2020-07804
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2021
• Device Model Number: 10677
• Device Catalogue Number: 10677
• Device Lot Number: 0023670279
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2019
• 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