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

Catalog Number 1009541-12B

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

Patient Problems Angina (1710); Ischemia (1942); Myocardial Infarction (1969); Test Result (2695)

Event Date 11/03/2013

Event Type  Injury  

Event Description

It was reported that 33 months post index procedure, the patient presented on an unspecified date with symptoms of chest heaviness and tightness which was initially improved with nitroglycerin but reoccurred.A stress test showed the presence of a small perfusion defect suggestive of ischemia; three sets of cardiac enzyme tests were reported to be negative.A cardiac catheterization identified a 70% diameter stenosis in the mid left anterior descending (lad) after the stent in the distal segment.There was a patent stent in the proximal to mid lad.A 2.5 x 38 mm unspecified drug-eluting stent (des) was deployed to the long segment of the mid lad.The subject tolerated the procedure well and was discharged on (b)(6) 2013.No additional information was provided.

Manufacturer Narrative

(b)(4).It was not possible to perform a thorough analysis on the product because it was not returned for investigation.In this case, there were no reported device malfunctions or product deficiencies.The reported patient effects of angina, ischemia, and myocardial infarction, are listed in the promus everolimus eluting coronary stent system instructions for use (ifu) as known patient effects of coronary stenting procedures.Although a conclusive cause for the reported patient effects and the relationship to the device if any cannot be determined, there is no indication of a product quality deficiency with respect to manufacture, design, or labeling.

Manufacturer Narrative

(b)(4).The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.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): CLONMEL, IRELAND REG# 9616693; 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: 3550970
• MDR Text Key: 3982875
• Report Number: 2024168-2014-00061
• 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,Followup
• Report Date: 12/10/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2012
• Device Catalogue Number: 1009541-12B
• Device Lot Number: 0042341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2010
• 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
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 49 YR