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

Catalog Number 1120300-38

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

Patient Problems Angina (1710); Headache (1880); Claudication (2550); No Code Available (3191)

Event Date 08/03/2016

Event Type  Injury  

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.

Event Description

It was reported that the procedure was to treat an unspecified lesion in the left anterior descending artery.On (b)(6) 2016 a 3x38mm xience alpine stent was implanted.Approximately 15 days later the patient began feeling pain in the arm and chest.The pain increased over time and the patient could not walk due to pain in the legs.The patient experienced headaches and pain in the neck.The patient went to a local clinic for his symptoms but the clinic referred the patient to a hospital.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.Additionally, the treatment appears to be related to the operational context of the procedure.Angina, fatigue, headache, and pain are listed in the xience alpine everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to filing the initial mdr, additional information was received which indicates that the patient was experiencing chest and arm pain before and after stent implantation.On (b)(6) 2016, 15 days after the stent was implanted the patient became symptomatic with the following: pain the in the legs, arms and chest, headaches, tickling and numbness in his head, eyes and neck and fatigue after walking.The patient was admitted to hospital (b)(6) emergency room (er) on (b)(6) 2016 where the attending physician provided the patient with injections of voltaren.On (b)(6) 2016 an electrocardiogram (ekg) was performed by a general practitioner and results were slightly abnormal.A myocardial infarction was not diagnosed.No angiogram was performed; thus, the status of the stent was unknown.It was confirmed, however, that the patient continues taking plavix.Although the patient does not have test results an appointment was scheduled for (b)(6) 2017 at (b)(6) hospital with a cardiologist.No further information was provided.

• Brand Name: XIENCE ALPINE 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: 6038617
• MDR Text Key: 57774436
• Report Number: 2024168-2016-07057
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Patient
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/04/2016

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
• Device Catalogue Number: 1120300-38
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/28/2016
• Initial Date FDA Received: 10/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/04/2016
• 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; Other
• Patient Age: 57 YR