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

Model Number 10676

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

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/07/2021

Event Type  malfunction  

Event Description

It was reported that stent damage occurred.Vascular access was obtained via right femoral artery.The 90% stenosed, concentric, de novo target lesion containing >45 and <90 degrees bend was located in the moderate to severely tortuous and moderately calcified right coronary artery.After engaging the lesion with a 6f jr 3.5 guide catheter and a non-bsc wire, pre-dilatation was performed with a non-bsc balloon.A 32 x 3.50 promus elite mr drug eluting stent was advanced to treat the lesion.However, the device failed to cross lesion and the stent strut was damaged.The device was removed and the procedure was completed with another of the same device.There were no complications reported and the patient was stable.

Event Description

It was reported that stent damage occurred.Vascular access was obtained via right femoral artery.The 90% stenosed, concentric, de novo target lesion containing >45 and <90 degrees bend was located in the moderate to severely tortuous and moderately calcified right coronary artery.After engaging the lesion with a 6f jr 3.5 guide catheter and a non-bsc wire, pre-dilatation was performed with a non-bsc balloon.A 32 x 3.50 promus elite mr drug eluting stent was advanced to treat the lesion.However, the device failed to cross lesion and the stent strut was damaged.The device was removed and the procedure was completed with another of the same device.There were no complications reported and the patient was stable.

Manufacturer Narrative

Device evaluated by mfr: promus elite ous mr 32 x 3.50mm stent delivery system catheter was returned for analysis.A visual examination of the stent found stent damage with struts in the distal region lifted from crimped position and pulled distally.The undamaged stent outer diameter was measured and the result was within maximum 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 multiple hypotube kinks.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.

• Brand Name: PROMUS ELITE
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11174205
• MDR Text Key: 227018772
• Report Number: 2134265-2021-00337
• 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: 02/25/2021

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: 05/15/2021
• Device Model Number: 10676
• Device Catalogue Number: 10676
• Device Lot Number: 0023865218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 02/18/2021
• Supplement Dates FDA Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR