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

Model Number 9554

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that stent damage occurred.The target lesion was located in the left circumflex artery.A 38 x 2.50 promus premier drug-eluting stent was selected for use; however, during unpacking, it was found that the stent struts were lifted.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.

Event Description

It was reported that stent damage occurred.The target lesion was located in the left circumflex artery.A 38 x 2.50 promus premier drug-eluting stent was selected for use; however, during unpacking, it was found that the stent struts were lifted.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluation by mfr.: promus premier ous mr 38 x 2.50mm stent delivery system was returned for analysis.A visual examination of the stent found stent damage.The most proximal stent struts were lifted from their crimped position.The undamaged stent outer diameter was measured and the result 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 visual examination of the bumper tip found no issues.A visual and tactile examination of the hypotube found no issues.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.

• Brand Name: PROMUS PREMIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10429216
• MDR Text Key: 203642721
• Report Number: 2134265-2020-11380
• 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: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2021
• Device Model Number: 9554
• Device Catalogue Number: 9554
• Device Lot Number: 0024682058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Date Manufacturer Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 70