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

Model Number 9309

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

Patient Problems Death (1802); Sudden Cardiac Death (2510)

Event Date 06/27/2019

Event Type  Death  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that sudden cardiac arrest and death occurred.Vascular access was obtained via the femoral artery.A percutaneous transluminal coronary angioplasty (ptca) was performed on an 80% stenosed target lesion in the non calcified, non tortuous left anterior descending artery (lad) and obtuse marginal (om).Following predilatation, a 3.00 x 38mm promus element long was deployed in the distal lad, a 3.50 x 16mm promus element was deployed in the proximal lad, and a 3.00 x 24mm promus element was deployed in the om.After three hours of ptca, the patient had sudden cardiac arrest and died in the coronary care unit (ccu) due to a reason unknown.

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that sudden cardiac arrest and death occurred.Vascular access was obtained via the femoral artery.A percutaneous transluminal coronary angioplasty (ptca) was performed on an 80% stenosed target lesion in the non calcified, non tortuous left anterior descending artery (lad) and obtuse marginal (om).Following predilitation, a 3.00 x 38mm promus element long was deployed in the distal lad, a 3.50 x 16mm promus element was deployed in the proximal lad, and a 3.00 x 24mm promus element was deployed in the om.After three hours of ptca, the patient had sudden cardiac arrest and died in the coronary care unit (ccu) due to a reason unknown.It was further reported that the patient was admitted with chest pain and angiograhically patient had significant stenosis in lad and om.At the time of the incident, the patient had sudden cardiac arrest and blood pressure (bp) had gone down.As an intervention, cpr was performed and patient was intubated on a ventilator.The patient died following the intervention.The timeframe between the sudden cardiac arrest and intervention was estimated to be around 90 minutes.The documented cause of death was sudden cardiac arrest.An autopsy and angiography were not performed after the event.

• Brand Name: PROMUS ELEMENT
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8754292
• MDR Text Key: 149825870
• Report Number: 2134265-2019-07667
• 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: 07/25/2019

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: 03/29/2020
• Device Model Number: 9309
• Device Catalogue Number: 9309
• Device Lot Number: 0022755943
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/28/2019
• Initial Date FDA Received: 07/02/2019
• Supplement Dates Manufacturer Received: 07/05/2019
• Supplement Dates FDA Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 65 YR