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

Model Number 10673

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Obstruction/Occlusion (2422)

Event Date 06/12/2020

Event Type  Death  

Manufacturer Narrative

Age at time of event: 18 years or older.Device is a combination product.

Event Description

It was reported that a death occurred.The 80% stenosed target lesion was located in the moderately tortuous and mildly calcified left anterior descending coronary artery.A 20 x 2.75mm promus elite drug-eluding stent was implanted with no issues reported.The patient expired post procedure but the physician considered the death as unlikely related to the device.

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported, that a death occurred.The 80% stenosed target lesion was located in the moderately tortuous, and mildly calcified left anterior descending coronary artery.A 20 x 2.75mm promus elite drug-eluding stent was implanted with no issues reported.The patient expired post procedure, but the physician considered, the death as unlikely related to the device.It was further reported, that the patient presented to the emergency room with severe angina with shock.And pulmonary edema with symptoms lasting approximately six hours.She was diagnosed with an anterior wall myocardial infarction and thrombolysed elsewhere unsuccessfully.She was taken to the cath lab for percutaneously coronary intervention, where she underwent angioplasty in the proximal left anterior descending coronary artery.Slow flow was obtained.The patient's hemodynamics failed to improve.And she died two days later, due to refractory shock, pulmonary edema and renal shutdown.

• 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: 10253449
• MDR Text Key: 198195336
• Report Number: 2134265-2020-09138
• 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: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2021
• Device Model Number: 10673
• Device Catalogue Number: 10673
• Device Lot Number: 0024858206
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 60 YR