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

Model Number 10675

Device Problems Difficult to Advance (2920); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 10/03/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: (b)(6).Age at time of event: patient is 18 years or older.

Event Description

It was reported that stent damage occurred.A 28x2.50mm promus elite mr drug-eluting stent was advanced for treatment.However, the device failed to pass through the guide catheter and the stent strut was deformed.The device was removed and the procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.

Manufacturer Narrative

Patient identifier: (b)(6).A2 age at time of event: patient is 18 years or older.Device evaluated by mfr.: promus elite ous mr 28 x 2.50mm stent delivery system was returned for analysis.A visual examination of the stent found the stent to be damaged on the distal and proximal ends with struts frayed.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 no signs of damage.A visual and tactile examination of the hypotube found multiple kinks.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.The device tracked without issues on a 0.0140" test guidewire.No other issues were identified during the product analysis.

Event Description

It was reported that stent damage occurred.A 28 x 2.50 promus elite mr drug-eluting stent was used for treatment.However, during preparation, stent was pushed through the guide catheter but could not pass through the guide catheter and was found to be deformed.The device was completely removed and the procedure was completed with another of the same device.There were no patient complications nor injuries 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: 10711035
• MDR Text Key: 212293703
• Report Number: 2134265-2020-14518
• 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: 12/06/2020

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: 11/03/2021
• Device Model Number: 10675
• Device Catalogue Number: 10675
• Device Lot Number: 0024768490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Initial Date Manufacturer Received: 10/07/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 11/23/2020
• Supplement Dates FDA Received: 12/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1