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

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

Patient Problems Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Neurological Deficit/Dysfunction (1982); Renal Failure (2041); Thrombosis (2100); Stenosis (2263)

Event Date 04/14/2014

Event Type  Injury  

Event Description

This event was captured based on literature review.It was reported through a research article identifying xience v stents and promus stent that may be related to the following: all-cause death, myocardial infarction, revascularization (restenosis), major bleeding, acute renal failure, stroke and stent thrombosis.Specific patient information is documented as unknown.Details are listed in the attached article.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event estimated as date of publication.Date of implant estimated.The reported patient effects of hemorrhage, myocardial infarction, renal failure, thrombosis, and restenosis, as listed in the xience v everolimus eluting coronary stent system electronic instructions for use are known patient effects that may be associated with the used of the device.Although a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined, there is no indication of a product quality deficiency with respect to manufacturing, design or labeling.The promus referenced, is being filed under a separate medwatch report.The additional adverse patient effect of death referenced, is being filed under a separate medwatch report.Attachment: perioperative complications after noncardiac surgery in patients with insertion of second-generation drug-eluting stents.

• Brand Name: XIENCE V 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: 4178345
• MDR Text Key: 5024653
• Report Number: 2024168-2014-06731
• 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: Literature
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/15/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2014
• Initial Date FDA Received: 10/16/2014
• 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
• Patient Outcome(s): Hospitalization; Required Intervention; Disability