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

Model Number 9392

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 12/20/2020

Event Type  Injury  

Event Description

It was reported that stent dislodgement occurred.The 95% stenosed, 2.75mmx32mm target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 2.75x32mm promus element plus drug-eluting stent was advanced for treatment.However, during procedure, the stent was dislodged.The device was completely removed all together without any issue and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

Event Description

It was reported that stent dislodgement occurred.The 95% stenosed, 2.75mmx32mm target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 2.75x32mm promus element plus drug-eluting stent was advanced for treatment.However, during procedure, the stent was dislodged.The device was completely removed all together without any issue and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, it was further reported that resistance was felt advancing the device to the lesion site.Multiple attempts were made to position the stent.The stent was expanded with another device post dislodgement and removed directly.

• 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: 11167331
• MDR Text Key: 226800434
• Report Number: 2134265-2020-18767
• 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
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2022
• Device Model Number: 9392
• Device Catalogue Number: 9392
• Device Lot Number: 0025431184
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/28/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 01/25/2021
• Supplement Dates FDA Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 64