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

Model Number 10673

Device Problem Difficult to Advance (2920)

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

Event Date 08/03/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: promus elite ous mr 20 x 3.00mm stent delivery system (sds), was returned for analysis.The product mandrel was inserted through the wire lumen.The mandrel was removed from the distal tip without issues.The following attributes were examined: stent profile: a visual and microscopic examination of the stent found struts in the mid to distal stent region lifted and pulled distally.The undamaged crimped stent od (outer diameter) was measured and was within maximum crimped stent profile measurement specifications.Balloon profile: 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.Tip profile: a visual and microscopic examination of the bumper tip found damage to the tip.Hypotube profile: a visual, microscopic and tactile examination of the hypotube found multiple inking along the hypotube.Shaft polymer extrusion profile: 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.Functional testing: the device was loaded onto a 0.014 inch sized guidewire with no resistance noted.

Event Description

Reportable based on device analysis completed on 27oct2021.It was reported that the promus elite ous mr 20 x 3.00 stent balloon expandable catheter could not cross through the guide catheter.No patient complications were reported.However, device analysis revealed stent damage.

• Brand Name: PROMUS ELITE
• 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: 12719338
• MDR Text Key: 279038652
• Report Number: 2134265-2021-13626
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: AR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2023
• Device Model Number: 10673
• Device Catalogue Number: 10673
• Device Lot Number: 0026655085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2021
• 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: 86 YR
• Patient Weight: 82