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

Model Number 10677

Device Problem Fracture (1260)

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

Event Date 03/25/2021

Event Type  Injury  

Event Description

It was reported that stent fracture occurred.Vascular access was obtained via the right femoral artery.The 90% stenosed, 3mmx28mm, concentric, de novo target lesion with a bend of >45 and <90 degrees was located in the left anterior descending artery.A 38 x 3.00 promus elite mr drug-eluting stent (des) was implanted; however, after the stent was post dilated with 3.25 nc balloon catheter, it was noticed that the stent connector broke in the proximal segment of the stent through stent boost.The physician used a 3.5x12mm promus elite des to cover the proximal stent area and the procedure completed.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

B5.Describe event or problem updated.Media review: a review of the media provided could not identify the alleged stent fracture however a gap which could indicate strut displacement was noted in the proximal to mid stent region.The apparent strut displacement noted could have appeared to the physician as stent fracture however this was not the case as the displaced struts visible in the photo review most likely represent a conformation of the stent (4-connector proximal (first 2 rows) and 2 connectors throughout and in the distal section design to the vessel anatomy by considering the presence of fibro-calcific lesions and provide the required scaffolding without any straightening of the vessel.Additionally the coplanar view from which we are seeing the stent could mislead to assume that there is a stent fracture when in fact what we are seeing is two strut connectors on the same plane on view (one behind the other), and this would be consistent with the stent image reviewed where struts are displaced in a v shape and connected in a central point.

Event Description

It was reported that stent fracture occurred.Vascular access was obtained via the right femoral artery.The 90% stenosed, 3mmx28mm, concentric, de novo target lesion with a bend of >45 and <90 degrees was located in the left anterior descending artery.A 38 x 3.00 promus elite mr drug-eluting stent (des) was implanted; however, after the stent was post dilated with 3.25 nc balloon catheter, it was noticed that the stent connector broke in the proximal segment of the stent through stent boost.The physician used a 3.5x12mm promus elite des to cover the proximal stent area and the procedure completed.No patient complications were reported and the patient's status was stable.It was further reported that the lesion was pre-dilated with 1.5mm rotalink plus and 3mmx12mm nc balloon at 18 atmospheres and was post-dilated with 3x12mm in distal and 3.25x12mm in the middle and 3.5x12mm in the proximal at 18 atmospheres.The lesion was not located in the bifurcation region.

Manufacturer Narrative

B5.Describe event or problem updated.

Event Description

It was reported that stent fracture occurred.Vascular access was obtained via the right femoral artery.The 90% stenosed, 3mmx28mm, concentric, de novo target lesion with a bend of >45 and <90 degrees was located in the left anterior descending artery.A 38 x 3.00 promus elite mr drug-eluting stent (des) was implanted; however, after the stent was post dilated with 3.25 nc balloon catheter, it was noticed that the stent connector broke in the proximal segment of the stent through stent boost.The physician used a 3.5x12mm promus elite des to cover the proximal stent area and the procedure completed.No patient complications were reported and the patient's status was stable.It was further reported that the lesion was pre-dilated with 1.5mm rotalink plus and 3mmx12mm nc balloon at 18 atmospheres and was post-dilated with 3x12mm in distal and 3.25x12mm in the middle and 3.5x12mm in the proximal at 18 atmospheres.The lesion was not located in the bifurcation region.

• 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: 11657224
• MDR Text Key: 245149900
• Report Number: 2134265-2021-04305
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2021

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: 10/28/2022
• Device Model Number: 10677
• Device Catalogue Number: 10677
• Device Lot Number: 0026305447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Initial Date Manufacturer Received: 03/26/2021
• Initial Date FDA Received: 04/13/2021
• Supplement Dates Manufacturer Received: 04/14/2021; 05/13/2021
• Supplement Dates FDA Received: 05/04/2021; 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER: 7F.; GUIDE CATHETER: 7F.; GUIDE CATHETER: 7F.; GUIDE CATHETER: 7F
• Patient Outcome(s): Required Intervention