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

Model Number 10675

Device Problems Failure to Advance (2524); Material Deformation (2976)

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

Event Date 10/21/2021

Event Type  malfunction  

Event Description

It was reported that stent damage occurred. Vascular access was obtained via the femoral artery. The target lesion containing a significant bend was located in the moderately tortuous and moderately calcified left anterior descending artery. A 28 x 2. 50 promus elite drug-eluting stent was advanced for treatment. However, during the procedure, the stent could not cross the lesion and it got damaged. The procedure was completed with another of same device. There were no patient complications reported and the patient status was stable.

Manufacturer Narrative

Age at time of event: 18 years or older. (b)(6).

• 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: 13120686
• MDR Text Key: 283151143
• Report Number: 2134265-2021-16353
• 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: Foreign,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/30/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 10675
• Device Catalogue Number: 10675
• Device Lot Number: 0026205476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial