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

Model Number 10676

Device Problem Failure to Advance (2524)

Patient Problem Death (1802)

Event Date 11/02/2020

Event Type  Death  

Event Description

It was reported a death occurred.The patient presented with slow flow.The target lesion was a tight lesion located in the ostium of the left anterior descending (lad) artery.A 38mm x 3.00mm promus elite drug-eluting stent was unable to cross the lesion and was removed.A 32mm x 3.00mm promus elite drug-eluting stent was advanced, but it also failed to cross the lesion.The patient then developed ventricular tachycardia.A 20mm x 3.00mm non-boston scientific stent was deployed, but failed to establish flow in the vessel and the patient died on the table.There is no other information available regarding the patient's medical history or concurrent medical conditions.

Event Description

It was reported a death occurred.The patient presented with slow flow the target lesion was a tight lesion located in the ostium of the left anterior descending (lad) artery.A 38 x 3.00 promus elite drug eluting stent was unable to cross the lesion and was removed.A 32 x 3.00 promus elite drug eluting stent was advanced, but it also failed to cross the lesion.The patient then developed ventricular tachycardia.A 20 x 3.00 non-boston scientific stent was deployed, but failed to establish flow in the vessel and the patient died on the table.

Manufacturer Narrative

Device evaluated by mfr: a 32 x 3.00mm promus elite stent delivery system was returned for analysis.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The crimped stent od (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 multiple kinks.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: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10869952
• MDR Text Key: 217175560
• Report Number: 2134265-2020-15713
• 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: 01/11/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2021
• Device Model Number: 10676
• Device Catalogue Number: 10676
• Device Lot Number: 0024703620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 11/19/2020
• Supplement Dates Manufacturer Received: 12/29/2020
• Supplement Dates FDA Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 38 YR