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

Model Number 9305

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2018

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 coronary artery.A 2.25x16mm promus element stent was advanced to treat the lesion.However, it was noted that the stent struts were lifted.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device is a combination product.Promus element, mr, ous 2.25 x 16 mm stent delivery system (sds) was returned for analysis.A visual examination of the stent found damage to distal stent rows with stent struts lifted and pulled distally.The undamaged crimped stent od (outer diameter) was measured within maximum crimped stent profile measurement.The tip was visually and microscopically examined and no damage was noted.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 tactile examination of the hypotube found no issues.A visual and tactile 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.

Event Description

It was reported that stent damage occurred.The target lesion was located in the left coronary artery.A 2.25x16mm promus element stent was advanced to treat the lesion.However, it was noted that the stent struts were lifted.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

• Brand Name: PROMUS ELEMENT
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8185288
• MDR Text Key: 131044708
• Report Number: 2134265-2018-64574
• 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: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/25/2018
• Device Model Number: 9305
• Device Catalogue Number: 9305
• Device Lot Number: 0020840739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Date Manufacturer Received: 01/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 65