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

Catalog Number 1125325-23

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

Patient Problems Angina (1710); Stroke/CVA (1770); Nausea (1970); Neurological Deficit/Dysfunction (1982); Dizziness (2194)

Event Date 12/18/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Relevant tests/laboratory data, including dates: on (b)(6) 2015: ecg=no myocardial infarction; on (b)(6) 2015 (08:29): ck=44 u/l, normal upper limit 192; on (b)(6) 2015 (08:29): ck-mb=1.4 ng/ml, normal upper limit 2.9; on (b)(6) 2015 (08:29): troponin i=0.03 ng/ml, upper reference limit 0.03; on (b)(6) 2015: ecg=no new myocardial infarction; on (b)(6) 2015 (16:25): ck-mb=1.0 ng/ml, normal upper limit 4.9; on (b)(6) 2015 (16:25): troponin i=0.03 ng/ml, upper reference limit 0.03.(b)(4).It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.The investigation was unable to determine a definitive cause for the patient effect.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of angina and nausea, as listed in the xience alpine everolimus eluting coronary stent system electronic instructions for use are known patient effects that may be associated with use of a coronary stent in native coronary arteries.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 issue with respect to manufacturing, design or labeling.

Event Description

It was reported that on (b)(6) 2015, the patient underwent a coronary procedure with implantation of a 3.25 x 23 mm xience alpine stent in the mid left anterior descending artery.Post procedure, the patient experienced altered mental status, evidenced by dizziness, difficulty speaking and nausea.Computed tomography (ct) scan and magnetic resonance imaging (mri) were ordered.Mri showed a tiny acute left cerebellar infarction.No intervention or treatment was performed.The patient underwent physical therapy, speech therapy and occupational therapy evaluation.The patient had full neurological recovery on (b)(6) 2015.On (b)(6) 2015, the patient experienced a non-serious episode of angina, with shortness of breath and jaw pain.Medication (nitrates) was administered and the angina resolved the day of onset.No additional 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): CLONMEL, IRELAND REG# 9616693; 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: 5365299
• MDR Text Key: 35918570
• Report Number: 2024168-2016-00232
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2018
• Device Catalogue Number: 1125325-23
• Device Lot Number: 5090841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• 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): Disability
• Patient Age: 70 YR
• Patient Weight: 81