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

Model Number 9554

Device Problems Contamination (1120); Packaging Problem (3007)

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

Event Date 07/28/2022

Event Type  malfunction  

Event Description

It was reported device contamination occurred.A 38 x 2.50 promus premier drug-eluting stent was selected for use.However, during unpacking, it was found that the package was damaged and the sterility of the device was compromised.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.

Manufacturer Narrative

Device evaluated by mfr.: promus elite ous mr 38 x 2.50mm stent delivery system was returned for analysis.The device returned in its opened packaging.The blue tab was opened.The outer box had no visible scuff marks or unusual damage and no damage was noted to the carton or opened foil packaging.The carrier hoop had no visible issues.No product mandrel or stent protector were returned with the device.A visual examination of the stent found stent damage.Stent struts on the distal end were lifted and pulled from the crimped profile.The undamaged stent 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 no signs of distal tip damage.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 along the shaft polymer extrusion.No other issues were identified during analysis.

Event Description

It was reported device contamination occurred.A 38 x 2.50 promus premier drug-eluting stent was selected for use.However, during unpacking, it was found that the package was damaged and the sterility of the device was compromised.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.

• Brand Name: PROMUS PREMIER
• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15234563
• MDR Text Key: 299570703
• Report Number: 2124215-2022-30668
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• 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: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2023
• Device Model Number: 9554
• Device Catalogue Number: 9554
• Device Lot Number: 0028126451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2021
• 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 Age: 62 YR
• Patient Sex: Male
• Patient Weight: 66 KG