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

Model Number 10667

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

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

Event Date 12/13/2021

Event Type  malfunction  

Event Description

It was reported that stent damage occurred. Vascular access was obtained via the femoral artery. The 90% stenosed, 44mm x 3. 00 mm, de novo target lesion was located in the mildly tortuous and moderately calcified right coronary artery. Following pre-dilation, a 3. 00 x 48mm synergy drug-eluting stent (des) and a 32 x 3. 00mm promus premier select des were advanced for treatment. However, both devices failed to cross the lesion and the stent struts got damaged. Both devices were removed and the procedure was successfully completed with a 2. 50x24mm and 3. 00x24mm promus premier select des. No patient complications were reported and the patient status was stable.

• Brand Name: PROMUS PREMIER SELECT
• 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: 13120260
• MDR Text Key: 283151235
• Report Number: 2134265-2021-16355
• 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,Distributor

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/04/2022

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: 10667
• Device Catalogue Number: 10667
• Device Lot Number: 0027666162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial