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

Model Number 10672

Device Problem Contamination (1120)

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

Event Date 03/01/2023

Event Type  malfunction  

Event Description

It was reported that device contamination occurred.Vascular access was obtained via radial artery.The 100% stenosed, total occluded, concentric and de novo target lesion was located in the mildly tortuous left circumflex artery.A 16 x 2.25 promus elite drug-eluting stent was selected for use.However, de sterilization occurred.No further information was available at time of reporting.

Manufacturer Narrative

B3 date of event: used the first date of the month of the aware date as no event date was provided.

Manufacturer Narrative

B3 date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr: promus elite ous mr 16 x 2.25mm stent delivery system was returned for analysis.The device packaging was not returned for analysis.A visual and microscopic examination of the crimped stent found no damages.The stent showed no signs of movement and was set between the proximal and distal marker bands.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 found no issues.A visual and tactile examination of the hypotube 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 along the shaft polymer extrusion.

Event Description

It was reported that device contamination occurred.Vascular access was obtained via radial artery.The 100% stenosed, total occluded, concentric and de novo target lesion was located in the mildly tortuous left circumflex artery.A 16 x 2.25 promus elite drug-eluting stent was selected for use.However, de sterilization occurred.No further information was available at time of reporting.

• Brand Name: PROMUS ELITE
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16733927
• MDR Text Key: 313633471
• Report Number: 2124215-2023-17375
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: MO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2023
• Device Model Number: 10672
• Device Catalogue Number: 10672
• Device Lot Number: 0026797713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2021
• 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
• Patient Sex: Male