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

Model Number 9313

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2019

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that stent fracture occurred.Vascular access was obtained via the right femoral artery.The 80% stenosed, 30mmx2.5mm, concentric, de novo target lesion was located in the severely tortuous and mildly calcified left circumflex (lcx) artery.The lesion contained between a 45 and 90 degree bend.A 6f non-bsc guide catheter was engaged in lcx coaxially.A non-bsc guidewire was then advanced to the lesion, followed by pre-dilation with a 2x12mm non-bsc balloon catheter, leaving 40% residual stenosis in the lesion.A 2.50x32mm promus element drug-eluting stent was selected and advanced to cover the long lesion, however, the stent got fractured while deploying.The device was removed from the patient's body.No patient complications were reported and patient's status was stable.

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: promus element,mr,ous 2.50x32mm stent delivery system was returned for analysis.An examination of the crimped stent identified proximal stent damage; proximal stent struts lifted and pulled distally.The crimped stent od (outer diameter) of the undamaged section of the stent was measured and the result was within max crimped stent profile measurement.The balloon was 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 multiple hypotube kinks.A visual and tactile examination of the shaft polymer extrusion found no issues.An examination found no issues with the tip.No other issues were identified during the product analysis.

Event Description

It was reported that stent fracture occurred.Vascular access was obtained via the right femoral artery.The 80% stenosed, 30mmx2.5mm, concentric, de novo target lesion was located in the severely tortuous and mildly calcified left circumflex (lcx) artery.The lesion contained between a 45 and 90 degree bend.A 6f non-bsc guide catheter was engaged in lcx coaxially.A non-bsc guidewire was then advanced to the lesion, followed by pre-dilation with a 2x12mm non-bsc balloon catheter, leaving 40% residual stenosis in the lesion.A 2.50x32mm promus element drug-eluting stent was selected and advanced to cover the long lesion, however, the stent got fractured while deploying.The device was removed from the patient's body.No patient complications were reported and 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: 8768757
• MDR Text Key: 150305728
• Report Number: 2134265-2019-07333
• 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: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2020
• Device Model Number: 9313
• Device Catalogue Number: 9313
• Device Lot Number: 0022846735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Date Manufacturer Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR