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

Model Number 9390

Device Problems Failure to Advance (2524); Material Deformation (2976); Material Integrity Problem (2978)

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

Event Date 12/21/2020

Event Type  malfunction  

Event Description

It was reported that stent damage occurred.The stenosed target lesion was located in the left circumflex artery.A 2.50x28mm promus element plus drug eluting stent advanced for treatment.However, the stent failed to cross the lesion and a defect was noted at the tip end.The procedure was completed with another of the same device.There were no complications reported and the patient status was stable.

Manufacturer Narrative

D4 - lot number: updated batch/lot# from 25420212 to 22724553.Device evaluated by mfr: promus element plus,mr,ous 2.50x28 mm stent delivery system was returned for analysis.An examination of the crimped stent found stent damage.Stent struts from the mid regions of the stent were noted to be lifted and pulled in all direction.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 and microscopic examination of the bumper tip showed no signs of tip damage.A visual and tactile examination of the hypotube 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.No other issues were identified during the product analysis.

Event Description

It was reported that stent damage occurred.The stenosed target lesion was located in the left circumflex artery.A 2.50x28mm promus element plus drug eluting stent advanced for treatment.However, the stent failed to cross the lesion and a defect was noted at the tip end.The procedure was completed with another of the same device.There were no complications reported and the patient status was stable.It was further reported that it was the tip of the catheter that has a defect and not the stent strut.

Manufacturer Narrative

B5 - describe event or problem updated.D4 - lot number: updated batch/lot# from 25420212 to 22724553.

Event Description

It was reported that stent damage occurred.The stenosed target lesion was located in the left circumflex artery.A 2.50x28mm promus element plus drug eluting stent advanced for treatment.However, the stent failed to cross the lesion and a defect was noted at the tip end.The procedure was completed with another of the same device.There were no complications reported and the patient status was stable.It was further reported that it was the tip of the catheter that has a defect and not the stent strut.

Manufacturer Narrative

B5 - describe event or problem updated.

Event Description

It was reported that stent damage occurred.The stenosed target lesion was located in the left circumflex artery.A 2.50x28mm promus element plus drug eluting stent advanced for treatment.However, the stent failed to cross the lesion and a defect was noted at the tip end.The procedure was completed with another of the same device.There were no complications reported and the patient status was stable.It was further reported that it was the tip of the catheter that has a defect and not the stent strut.

• 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: 11100014
• MDR Text Key: 224530103
• Report Number: 2134265-2020-18618
• 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,Followup,Followup
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2020
• Device Model Number: 9390
• Device Catalogue Number: 9390
• Device Lot Number: 0022724553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 53