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

Catalog Number 1017300-12

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

Patient Problem Unspecified Infection (1930)

Event Date 02/11/2014

Event Type  Injury  

Manufacturer Narrative

A partial udi is being reported because the lot number was not provided.The xience pro is currently not commercially available in the u.S.; however, it is similar to a device sold in the u.S.There was no reported device malfunction and the product was not returned.A review of the lot history record was not performed because the lot number.Based on the information reviewed, there is no indication of a product quality issue.Viral, bacterial, and fungal infections are listed in the xience pro everolimus eluting coronary stent systems instructions for use (ifu) as known patient effects of coronary stenting procedures.Additionally, based on the reported information, the reported infection appears not related to the device.Based on the case information, a conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined.

Event Description

It was reported that the patient presented with atherosclerotic cardiac disease.A 3.0x12mm xience pro stent and a 3.0x28mm implant were implanted on (b)(6) 2014.The patient was discharged from the hospital on (b)(6) 2014.The patient returned to the emergency room later on (b)(6) 2014 complaining of headache, cold sweating and high temperature and was discharged a few days later after a few hours of treatment with a serum process.The very next day, (b)(6) 2014, the patient returned with the same adverse patient effects and was again hospitalized in the cardiology service.Tests were performed and it was determined on (b)(6) 2014 that the patient had developed a pseudomonas infection.Reportedly, the infection is due to the hospital care and not due to the implants.No additional information was provided.

• Brand Name: XIENCE PRO EVEROLIMUS ELUTING RX 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 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5599705
• MDR Text Key: 43436618
• Report Number: 2024168-2016-02594
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1017300-12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2016
• 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