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

Model Number 10665

Device Problems Positioning Failure (1158); Failure to Advance (2524); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/20/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that stent damage occurred.During a percutaneous transluminal coronary angioplasty, a 24 x 3.00 promus premier select was advanced to the target lesion, but was unable to properly pass through the lesion and could not be deployed.The device was positioned at the lesion site, but the stent failed to deploy.The device was removed from the patient, and stent damage was noticed.It was noted that stent deployment was not performed due to the observed damage on the stent struts.The procedure was completed with another of the same device.No patient complications resulted in relation to this event, and the patient was reported to be stable following the procedure.

Event Description

It was reported that stent damage occurred.During a percutaneous transluminal coronary angioplasty, a 24 x 3.00 promus premier select was advanced to the target lesion, but was unable to properly pass through the lesion and could not be deployed.The device was positioned at the lesion site, but the stent failed to deploy.The device was removed from the patient, and stent damage was noticed.It was noted that stent deployment was not performed due to the observed damage on the stent struts.The procedure was completed with another of the same device.No patient complications resulted in relation to this event, and the patient was reported to be stable following the procedure.It was further reported that the lesion was located in the left anterior descending artery (lad), and that the stent damage occurred during the case.

Manufacturer Narrative

E1: initial reporter address - (b)(6).

Manufacturer Narrative

E1: initial reporter address - (b)(6).Device evaluated by mfr: a 24 x 3.00mm promus premier select stent delivery system (sds) was returned for analysis.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The stent od (outer diameter) was measured and the result was within max crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip showed signs of distal tip damage.A visual and tactile examination of the hypotube shaft found multiple kinks.A visual and tactile examination of the outer and mid shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.No other issues were identified during analysis.

Event Description

It was reported that stent damage occurred.During a percutaneous transluminal coronary angioplasty, a 24 x 3.00 promus premier select was advanced to the target lesion, but was unable to properly pass through the lesion and could not be deployed.The device was positioned at the lesion site, but the stent failed to deploy.The device was removed from the patient, and stent damage was noticed.It was noted that stent deployment was not performed due to the observed damage on the stent struts.The procedure was completed with another of the same device.No patient complications resulted in relation to this event, and the patient was reported to be stable following the procedure.It was further reported that the lesion was located in the left anterior descending artery (lad), and that the stent damage occurred during the case.It was further reported that there was no any attempt made to inflate the balloon.

• 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: 13102385
• MDR Text Key: 282911225
• Report Number: 2134265-2021-16278
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2022
• Device Model Number: 10665
• Device Catalogue Number: 10665
• Device Lot Number: 0025948022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1