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

Model Number 10663

Device Problems Difficult to Insert (1316); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2019

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that stent deformation occurred.A percutaneous coronary intervention was being performed on a 80% stenosed and mildly calcified lesion in the proximal right coronary artery.During insertion of the 16mm x 3.0mm promus premier select stent, resistance was felt.The stent was removed from the patient and the stent strut was noted to be sticking out.The procedure was successfully completed with a another of the same stent and the patient was stable following the procedure.

Manufacturer Narrative

Age at time of event: 18 years or older.A 16 x 3.00mm promus premier select stent delivery system was returned for analysis.The guide catheter used in the procedure was not returned for analysis.An examination (visual and via scope) of the crimped stent identified distal stent damage; damage was noted distal stent strut row 4 with the strut lifted and pushed distally.The undamaged crimped stent outer diameter was measured using snap gauge and 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 0.014 inch guidewire was inserted through the device without issue and a vacuum was applied using an encore inflation device.The device was then put through a 6f guide catheter.Slight resistance was encountered due to the stent damage; however, the device was successfully pushed through the guide catheter without issue.The device was also removed from the guide catheter without issue.A visual and tactile examination of the hypotube found no issues.A visual and tactile examination of the shaft polymer extrusion found no issues.A visual and microscopic examination found tip damage.No other issues were identified during the product analysis.

Event Description

It was reported that stent deformation occurred.A percutaneous coronary intervention was being performed on a 80% stenosed and mildly calcified lesion in the proximal right coronary artery.During insertion of the 16mm x 3.0mm promus premier select stent, resistance was felt.The stent was removed from the patient and the stent strut was noted to be sticking out.The procedure was successfully completed with a another of the same stent and the patient was stable following the procedure.

• Brand Name: PROMUS PREMIER SELECT
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9224348
• MDR Text Key: 164328859
• Report Number: 2134265-2019-12429
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10663
• Device Catalogue Number: 10663
• Device Lot Number: 0024184269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Date Manufacturer Received: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1