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

Model Number 10667

Device Problems Positioning Failure (1158); Failure to Advance (2524); Material Deformation (2976); Material Integrity Problem (2978)

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

Event Date 02/10/2022

Event Type  malfunction  

Event Description

It was reported that stent damage occurred.A percutaneous coronary intervention was being performed using a 12 x 2.50 promus premier select stent for treatment.During the procedure, the device would not pass through the lesion.It was positioned at the lesion, but would not deploy.The physician removed the device from the patient, and stent damage was noticed on the strut.The damaged stent was replaced with another of the same device, and the procedure was completed.No patient complications resulted as of this event.

Manufacturer Narrative

Device evaluated by mfr: a 32 x 2.50mm promus premier select stent delivery system was returned for analysis.A visual examination of the stent found signs of stent damage.The distal portion of the crimped stent was found to be stretched distally out over the tip of the device.The undamaged stent od (outer diameter) was measured using snap gauge 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 and hypotube found no issues.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen identified no issues.

Event Description

It was reported that stent damage occurred.A percutaneous coronary intervention was being performed using a 12 x 2.50 promus premier select stent for treatment.During the procedure, the device would not pass through the lesion.It was positioned at the lesion, but would not deploy.The physician removed the device from the patient, and stent damage was noticed on the strut.The damaged stent was replaced with another of the same device, and the procedure was completed.No patient complications resulted as of this event.

• 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: 13573140
• MDR Text Key: 286002299
• Report Number: 2134265-2022-01930
• 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
• Type of Report: Initial,Followup
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2023
• Device Model Number: 10667
• Device Catalogue Number: 10667
• Device Lot Number: 0027377280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/14/2022
• Initial Date FDA Received: 02/21/2022
• Supplement Dates Manufacturer Received: 03/14/2022
• Supplement Dates FDA Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1