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

Model Number 9386

Device Problems Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that stent damage occurred.Vascular access was obtained via the right femoral artery.The 80-90% stenosed, 16mm in length, concentric, de novo target lesion with a bend of >45 and <90 degrees was located in the moderately tortuous and moderately calcified, 4mm in diameter right coronary artery.After a non-boston scientific guide catheter was engaged and a non-boston scientific guidewire crossed the lesion, pre-dilation was performed with a 2 x 12 maverick balloon catheter, leaving 40% residual stenosis in the lesion.A 4.00x20mm promus element plus drug-eluting stent was advanced for treatment but failed to cross the lesion.Pre-dilation was performed again with the same balloon but still, the stent could not track.Resistance was encountered while trying to cross the lesion, so the stent was pulled back, and noted that the stent struts were lifted and damaged.The device was removed, and the procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.

Manufacturer Narrative

E1: initial reporter first name - (b)(6).Device evaluated by mfr.: promus element plus,mr,ous 4.00x20mm stent delivery system was returned for analysis.A visual examination of the stent found stent damage.Stent struts from the proximal end of the stent lifted and pulled distally.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 showed no signs of damage.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.

Event Description

It was reported that stent damage occurred.Vascular access was obtained via the right femoral artery.The 80-90% stenosed, 16mm in length, concentric, de novo target lesion with a bend of >45 and <90 degrees was located in the moderately tortuous and moderately calcified, 4mm in diameter right coronary artery.After a non-boston scientific guide catheter was engaged and a non-boston scientific guidewire crossed the lesion, pre-dilation was performed with a 2 x 12 maverick balloon catheter, leaving 40% residual stenosis in the lesion.A 4.00x20mm promus element plus drug-eluting stent was advanced for treatment but failed to cross the lesion.Pre-dilation was performed again with the same balloon but still, the stent could not track.Resistance was encountered while trying to cross the lesion, so the stent was pulled back, and noted that the stent struts were lifted and damaged.The device was removed, and the procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.

• 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: 10679184
• MDR Text Key: 211458726
• Report Number: 2134265-2020-14201
• 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: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2021
• Device Model Number: 9386
• Device Catalogue Number: 9386
• Device Lot Number: 0024499197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: 11/23/2020
• Supplement Dates FDA Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER: JUDKINS RIGHT 3; GUIDE CATHETER: JUDKINS RIGHT 3; GUIDEWIRE: RUNTHROUGH & GRAND SLAM WIRE; GUIDEWIRE: RUNTHROUGH & GRAND SLAM WIRE
• Patient Age: 54 YR