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

Model Number 10666

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2020

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that stent damage occurred.As the 28 x 3.5 promus premier select drug-eluting stent was taken out of the packaging, the physician noticed that the stent was damaged.The stent was never used, therefore posed no risk to the patient.Another of the same device was used to complete the procedure successfully and without any patient injury.

Manufacturer Narrative

Device returned to manufacturer: a visual examination of the stent found that the stent was damaged with stent struts from the distal region of the stent lifted and pulled proximally.The undamaged section crimped stent outer diameter was measured and the result was 0.0435, this is within maximum crimped stent profile measurement as per document.Stent damage most likely occurred due to handling during unpacking.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 examination of the tip showed no signs of damage.A visual and tactile examination of the hypotube found no issues with the hypotube shaft.A visual and tactile examination of the outer lumen and mid-shaft section and a visual examination of the inner lumen found no issues with the extrusion shaft.No other issues were identified during the product analysis.

Event Description

It was reported that stent damage occurred.As the 28 x 3.5 promus premier select drug-eluting stent was taken out of the packaging, the physician noticed that the stent was damaged.The stent was never used, therefore posed no risk to the patient.Another of the same device was used to complete the procedure successfully and without any patient injury.

• 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: 10473296
• MDR Text Key: 204997647
• Report Number: 2134265-2020-11954
• 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: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2021
• Device Model Number: 10666
• Device Catalogue Number: 10666
• Device Lot Number: 0024523972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Date Manufacturer Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1