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

Lot Number 0025102588

Device Problem Defective Device (2588)

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

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

Event date: used the first day of the month of aware date since there was no date provided.

Event Description

It was reported that stent damage occurred resulting in additional stenting.The target lesion was located in the proximal left anterior descending (lad) artery.A 3.0x16mm promus elite mr balloon expandable drug eluting stent was selected for use to treat what appears to be a calcified dissection flap or nodular calcium within the proximal lad.The lesion was predilated with a 3.0mm emerge balloon catheter.The promus elite stent was advanced and deployed.Upon inflation and cine, it appeared that the stent had moved backwards into the left main.Using a stent boost to confirm, it appeared that the stent had longitudinal deformation as the stent was visibly longer than the balloon markers from stent delivery system.The distal cells appeared elongated and stretched out.Culotte bifurcation stenting was then performed at the ostial circumflex and left main to rescue the jailed circumflex.There were no patient complications reported.Patient status was stable.

Event Description

It was reported that stent damage occurred resulting in additional stenting.The target lesion was located in the proximal left anterior descending (lad) artery.A 3.0x16mm promus elite mr balloon expandable drug eluting stent was selected for use to treat what appears to be a calcified dissection flap or nodular calcium within the proximal lad.The lesion was predilated with a 3.0mm emerge balloon catheter.The promus elite stent was advanced and deployed.Upon inflation and cine, it appeared that the stent had moved backwards into the left main.Using a stent boost to confirm, it appeared that the stent had longitudinal deformation as the stent was visibly longer than the balloon markers from stent delivery system.The distal cells appeared elongated and stretched out.Culotte bifurcation stenting was then performed at the ostial circumflex and left main to rescue the jailed circumflex.There were no patient complications reported.Patient status was stable.

Manufacturer Narrative

B3 date of event: used the first day of the month of aware date since there was no date provided.Device evaluated by mfr: promus elite us mr 16 x 3.00 mm stent delivery system (sds) was returned for analysis.The device was returned without the stent as it was deployed successfully at the lesion site.A review of the manufacturing stent profile data was performed and the stent od at the time of manufacture was 0.041.This is within max crimped stent profile measurement.The balloon cones were reviewed, and signs of positive pressure applied to the cones were noted as the balloon was in a deflated state.A visual and microscopic examination of the bumper tip showed no issues.A visual and tactile examination of the hypotube found no issues.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.

• Brand Name: PROMUS ELITE
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11455292
• MDR Text Key: 238923254
• Report Number: 2134265-2021-02554
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

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: 07/11/2021
• Device Lot Number: 0025102588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Initial Date Manufacturer Received: 02/19/2021
• Initial Date FDA Received: 03/10/2021
• Supplement Dates Manufacturer Received: 04/13/2021
• Supplement Dates FDA Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention