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

Model Number 9392

Device Problems Obstruction of Flow (2423); Material Deformation (2976)

Patient Problem Thrombosis (2100)

Event Date 02/15/2020

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that thrombosis and stent damage occurred.Vascular access was obtained via the femoral artery.The 95% stenosed, 60mmx2.75mm, eccentric, de novo target lesion was located in the ostial and proximal right coronary artery.After a pt2 ls guidewire was placed, the target lesion was predilated with a 2.5x 20mm emerge balloon.A 2.50x32mm promus element plus drug-eluting stent was implanted in the target lesion.A 2.75x32mm promus element plus drug-eluting stent was also advanced for treatment.However, during positioning, the stent stopped outside of the ostium into the aorta and there was no back flow.When the 2.75x32mm device was removed, it was noted that the catheter was full of thrombi and that the stent had a distorted configuration.The procedure was completed with another 2.75x32mm promus element plus.There were no further patient complications and the patient's status was stable.

Event Description

It was reported that thrombosis and stent damage occurred.Vascular access was obtained via the femoral artery.The 95% stenosed, 60mmx2.75mm, eccentric, de novo target lesion was located in the ostial and proximal right coronary artery.After a pt2 ls guidewire was placed, the target lesion was predilated with a 2.5x 20mm emerge balloon.A 2.50x32mm promus element plus drug-eluting stent was implanted in the target lesion.A 2.75x32mm promus element plus drug-eluting stent was also advanced for treatment.However, during positioning, the stent stopped outside of the ostium into the aorta and there was no back flow.When the 2.75x32mm device was removed, it was noted that the catheter was full of thrombi and that the stent had a distorted configuration.The procedure was completed with another 2.75x32mm promus element plus.There were no further patient complications and the patient's status was stable.

Manufacturer Narrative

Device is a combination product: device evaluated by mfr.: promus element plus,mr,ous 2.75 x 32 mm stent delivery system catheter was returned for analysis.An examination visual and via scope of the crimped stent found stent damage.Stent struts from the proximal end of the stent were noted to be lifted from their crimped position and slightly flared opened around the proximal balloon cone and pulled distally.Stent struts form the distal end of the stent noted to be lifted and slightly flared (opened) around the distal balloon cone.The undamaged crimped stent outer diameter was measured and the result was within max crimped stent profile measurement.The balloon was reviewed and both proximal and distal balloon cone appeared slightly inflated with the balloon wings not tightly wrapped and folded.The balloon cones show signs of some positive pressure applied to them.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube shaft found no issues.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.No other issues were identified during the product analysis.

• Brand Name: PROMUS ELEMENT PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9733510
• MDR Text Key: 180583874
• Report Number: 2134265-2020-01829
• 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: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2021
• Device Model Number: 9392
• Device Catalogue Number: 9392
• Device Lot Number: 0023777678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Initial Date Manufacturer Received: 02/15/2020
• Initial Date FDA Received: 02/20/2020
• Supplement Dates Manufacturer Received: 04/08/2020
• Supplement Dates FDA Received: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 80