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

Model Number 10675

Device Problem Device Damaged by Another Device (2915)

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

Event Date 01/11/2021

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or above.

Event Description

It was reported that stent damage post deployment occurred.The target lesion was located in the moderately tortous and moderately calcified mid left anterior descending artery.A 28x4.00mm promus elite drug-eluting stent was advanced for treatment.While trying to do post-dilatation with a non-boston scientific balloon catheter, the non-boston scientific guide catheter caught the stent proximal edge and longitudinal stent deformation at the proximal end was noted.The physician then used a small balloon to larger balloon to partially rectify the deformity of the implanted stent and the procedure was completed.No patient complications were reported and the patient was doing well.

Manufacturer Narrative

(a2) age at time of event: 18 years or above.

Event Description

It was reported that stent damage post deployment occurred.The target lesion was located in the moderately tortous and moderately calcified mid left anterior descending artery.A 28x4.00mm promus elite drug-eluting stent was advanced for treatment.While trying to do post-dilatation with a non- boston scientific balloon catheter and non- boston scientific guide catheter caught the stent proximal edge and serious amount of longitudinal stent deformation at the proximal end was noted.The physician then used a small balloon to larger balloon to partially rectify the deformity of the implanted stent and the procedure was completed.No patient complications were reported and the patient was doing well.It was further reported that the stent was located at a bifurcation region and was deployed without issue.

Event Description

It was reported that stent damage post deployment occurred.The target lesion was located in the moderately tortous and moderately calcified mid left anterior descending artery.A 28x4.00mm promus elite drug-eluting stent was advanced for treatment.While trying to do post-dilatation with a non- boston scientific balloon catheter, a non- boston scientific guide catheter caught the stent proximal edge and serious amount of longitudinal stent deformation at the proximal end was noted.The physician then used a small balloon to larger balloon to partially rectify the deformity of the implanted stent and the procedure was completed.No patient complications were reported and the patient was doing well.It was further reported that the stent was located at a bifurcation region and was deployed without issue.

Manufacturer Narrative

(a2) age at time of event: 18 years or above.D9 device avail for evaluation? and returned to manufacturer date: corrected.The device was not returned for analysis.A review of media provided by the site identified the alleged stent deformation.The images provided showed a stent deployed at the lad/lcx bifurcation which was noted to be deformed in its proximal region.This deformation occurred not immediately post deployment but rather during balloon post dilations and was due to a possible interaction of the deployed stent with the distal end of the guide catheter.Serial balloon dilatations were shown which apparently resolved the stent deformation.

• 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: 11238135
• MDR Text Key: 228959941
• Report Number: 2134265-2021-00473
• 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: 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2022
• Device Model Number: 10675
• Device Catalogue Number: 10675
• Device Lot Number: 0026306998
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/08/2021
• Date Manufacturer Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention