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

Model Number 10673

Device Problems Difficult to Advance (2920); Material Deformation (2976)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older. Device is a combination product.

Event Description

It was reported that stent damage occured and the procedure was cancelled. Vascular access was obtained via radial artery. The 90% stenosed, 16mm x 3. 5mm, concentric, de novo, target lesion was located in the mildly tortuous and moderately calcified left anterior descending artery. After pre-dilation with 3. 00mm balloon catheter, a 20 x 3. 50 promus elite drug-eluting stent was advanced but failed to cross lesion and the stent strut got damaged. The device was removed and the procedure was cancelled. No patient complications were reported and the patient's status was stable.

• 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: 10471234
• MDR Text Key: 204917131
• Report Number: 2134265-2020-11113
• 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,distri

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/13/2022
• Device Model Number: 10673
• Device Catalogue Number: 10673
• Device Lot Number: 0025079624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial