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

Model Number 9384

Device Problem Material Deformation (2976)

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

Event Date 12/14/2020

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that stent damage occurred.The 90% stenosed target lesion was located in left anterior descending artery.A 2.25x16mm promus element plus drug-eluting stent was advanced for treatment.However, during procedure, the stent strut was lifted up.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.

Manufacturer Narrative

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

Event Description

It was reported that stent damage occurred.The 90% stenosed target lesion was located in left anterior descending artery.A 2.25x16mm promus element plus drug-eluting stent was advanced for treatment.However, during procedure, the stent strut was lifted up.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.It was further reported that target lesion was mildly tortuous and mildly calcified.

Manufacturer Narrative

A2: age at time of event: 18 years or older.Device evaluated by mfr.: a promus element plus,mr,ous 2.25 x 16mm stent delivery system was returned for analysis.A visual examination of the stent found evidence of damage with mid-section struts lifted.The undamaged crimped 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 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.The 90% stenosed target lesion was located in left anterior descending artery.A 2.25x16mm promus element plus drug-eluting stent was advanced for treatment.However, during procedure, the stent strut was lifted up.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.It was further reported that target lesion was mildly tortuous and mildly calcified.

• 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: 11099121
• MDR Text Key: 224530727
• Report Number: 2134265-2020-18609
• 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
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2021
• Device Model Number: 9384
• Device Catalogue Number: 9384
• Device Lot Number: 0024294489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1