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

Model Number 10666

Device Problems Positioning Failure (1158); Failure to Advance (2524); Difficult to Advance (2920); Material Deformation (2976)

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

Event Date 12/21/2021

Event Type  malfunction  

Event Description

It was reported that the struts were damaged.A 50% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending (lad) artery.A 28 x 2.75 promus premier select drug-eluting stent was selected for in a percutaneous transluminal coronary angioplasty (ptca).During the procedure, the stent was advanced, the device was positioned at the lesion site, but the stent was failed to be deployed.There was a multiple attempts made to position the stent at the lesion site.The physician removed the stent from patient and noticed the struts were damaged.The procedure completed successfully with another same device.There were no patient complications reported.

Event Description

It was reported that the struts were damaged.A 50% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending (lad) artery.A 28 x 2.75 promus premier select drug-eluting stent was selected for in a percutaneous transluminal coronary angioplasty (ptca).During the procedure, the stent was advanced, the device was positioned at the lesion site, but the stent was failed to be deployed.There was a multiple attempts made to position the stent at the lesion site.The physician removed the stent from patient and noticed the struts were damaged.The procedure completed successfully with another same device.There were no patient complications reported.It was further reported that there was no attempt made to inflate the balloon.

Manufacturer Narrative

H6: device codes: changed 'difficult to advance' code to "failure to advance' code.Device evaluated by manufacturer: a 28 x 2.75mm promus premier select stent delivery system was returned for analysis.A visual and microscope examination of the stent found that no damage.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 marker bands.The stent outer diameter (od) was measured and the result was within maximum 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 identified no issues.A visual and tactile examination of the hypotube shaft found no issues.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that the struts were damaged.A 50% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending (lad) artery.A 28 x 2.75 promus premier select drug-eluting stent was selected for in a percutaneous transluminal coronary angioplasty (ptca).During the procedure, the stent was advanced, the device was positioned at the lesion site, but the stent was failed to be deployed.There was a multiple attempts made to position the stent at the lesion site.The physician removed the stent from patient and noticed the struts were damaged.The procedure completed successfully with another same device.There were no patient complications reported.It was further reported that there was no 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13102212
• MDR Text Key: 282913034
• Report Number: 2134265-2021-16268
• 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: 02/25/2022

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: 03/31/2023
• Device Model Number: 10666
• Device Catalogue Number: 10666
• Device Lot Number: 0027127926
• 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: 02/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2021
• 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