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

Model Number 10671

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/25/2021

Event Type  Injury  

Manufacturer Narrative

A2.Age at time of event: 18 years or older.

Event Description

It was reported that stent profile problem occurred.Vascular access was obtained via the femoral artery.The target lesion was located in the left main artery.A 12 x 4.00 promus elite drug-eluting stent was advanced for treatment.However, it was noticed in the angiogram, that the stent appeared bigger than the vessel.The procedure was completed with another of same device.No patient complications were reported.

Manufacturer Narrative

A2.Age at time of event: 18 years or older.Device evaluated by mfr.: promus elite 12 x 4.00 mm stent delivery system was returned for analysis.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The crimped stent outer diameter and crimped stent length measured within maximum crimped stent profile and length 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 damage.A visual and tactile examination of the hypotube shaft found a kink situated at 38.2cm distal to the distal end of strain relief.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 profile problem occurred.Vascular access was obtained via femoral arter.The target lesios was located in the left main artery.A 12 x 4.00 promus elite drug-eluting stent was advanced for treatment.However, it was noticed in the angiogram, that the stent was appear bigger compare to vessel.The procedure was completed with another of the same device.No patient complications were reported.

• 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: 11546460
• MDR Text Key: 241732161
• Report Number: 2134265-2021-03002
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• 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: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2021
• Device Model Number: 10671
• Device Catalogue Number: 10671
• Device Lot Number: 0023829375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Date Manufacturer Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other