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 Hypersensitivity/Allergic reaction (1907); Rash (2033); Respiratory Distress (2045)

Event Date 01/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The stent remains in the patient and there was no reported device malfunction.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot number were not provided.The reported patient effects of hypersensitivity and rash are listed in xience everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined and there is no indication of a product quality issue with respect to manufacture, design or labeling.The other implanted xience stent referenced is filed under a separate medwatch report number.

Event Description

It was reported that in (b)(6) 2017, the patient underwent a coronary stenting procedure with implantation of two unspecified xience stents.Beginning almost immediately after the stenting procedure, the patient experienced a rash over the trunk area mainly, but also on other parts of the body.Over-the-counter cortisone cream was used, with little effect.The patient had one episode of breathing issues, where it felt like the airway was closing, which was treated with a steroid medication.The episode resolved and the patient has not had other similar episodes.The rash has never gone away.The patient is being seen by a cardiologist and an allergist.No additional information was provided.

• 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 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: 6679779
• MDR Text Key: 78764588
• Report Number: 2024168-2017-05541
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/19/2017
• 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: OTHER IMPLANTED XIENCE STENT
• Patient Outcome(s): Required Intervention