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

Model Number 10673

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 06/15/2020

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.Age at time of event: above 18 years and older.

Event Description

It was reported that stent damage occurred.A 20 x 4.00mm promus elite drug-eluting stent was selected for use.However, it was noted that the distal edge of the stent strut was opened while preparing to load on the wire.The procedure was completed with another stent.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device is a combination product.A2: age at time of event: above 18 years and older.Device evaluated by mfr.: promus elite ous mr 20 x 4.00 stent delivery system was returned for analysis.A visual examination of the stent found a damaged stent - stent struts from the distal end of the stent were lifted and pulled distally.The undamaged stent outer diameter 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 showed signs of damage.A visual and tactile examination of the hypotube found no issues.Visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found the inner polymer extrusion lumen detached at 5mm distal of the exchange port and bunched distally.No other issues were identified during the product analysis.

Event Description

It was reported that stent damage occurred.A 20 x 4.00mm promus elite drug-eluting stent was selected for use.However, it was noted that the distal edge of the stent strut was opened while preparing to load on the wire.The procedure was completed with another stent.No patient complications were reported and the patient's status was stable.

• Brand Name: PROMUS ELITE
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10330162
• MDR Text Key: 200605940
• Report Number: 2134265-2020-09986
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2021
• Device Model Number: 10673
• Device Catalogue Number: 10673
• Device Lot Number: 0024567924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Date Manufacturer Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1