MAUDE Adverse Event Report: AV-TEMECULA-CT PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Stenosis (2263)

Event Date 01/01/2010

Event Type  Death  

Event Description

It was reported that prior to the procedure in which the promus stents were deployed, the patient underwent catheterization which revealed significant triple vessel coronary artery disease.In 2005, the patient had elective angioplasty of the saphenous vein graft (svg) to diagonal branch during which a non-abbott drug eluting stent was deployed.In 2008, the patient presented to hospital in cardiac arrest and complete heart block and catheterization revealed 99% stenosis of the svg to the diagonal branch.Percutaneous coronary intervention of the svg to the diagonal branch for proximal and distal stenoses was performed and a pacemaker was placed as arrhythmia was believed to be the cause of arrest.Two (2) promus stents were deployed, 1 in distal vein graft, 1 in proximal graft.In 2010, the right coronary artery proximal had a 100% occlusion, the left main distal 80-90% stenosis with calcification, and the left anterior descending artery had a 100% proximal occlusion.The circumflex artery was 100% proximally occluded and the saphenous vein graft to the diagonal branch had 99% in-stent restenosis of the distal promus stented segment.The in-stent restenosis was treated with the placement of a non-abbott stent.It was learned from the patients obituary that the patient died on (b)(6) 2012.No additional information was provided.

Manufacturer Narrative

(b)(4).The reported patient effects of restenosis and death, as listed in the promus everolimus eluting coronary stent system instructions for use are known patient effects that may be associated with the used of the device.You are receiving this mdr report from abbott vascular because boston scientific corporation distributes promus as its own brand labeling of abbott vasculars drug eluting stent in the us.

• Brand Name: PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 3944148
• MDR Text Key: 4537817
• Report Number: 2024168-2014-04626
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Health Professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: STENT: PROMUS
• Patient Outcome(s): Death
• Patient Age: 84 YR
• Patient Weight: 111