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

Catalog Number 1011710-18

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

Patient Problems Angina (1710); Arrhythmia (1721); Headache (1880); Weakness (2145); Dizziness (2194)

Event Date 01/19/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).On (b)(6) 2015, the patient experienced a headache after changing position and unstable angina was diagnosed.The patient was hospitalized and medication was provided.The event resolved.On (b)(6) 2015, the patient experienced intermittent chest tightness and chronic coronary insufficiency was diagnosed.The patient was hospitalized and medication was provided.The event resolved.On (b)(6) 2015, the patient experienced precordial discomfort, heart palpitations, and dizziness with no known cause.Unstable angina was diagnosed and the patient was hospitalized and medication was provided.The event resolved.On (b)(6) 2015, the patient experienced intermittent precordial discomfort and unstable angina was diagnosed.The patient was hospitalized and medication was provided.The event resolved.On (b)(6) 2015, the patient experienced precordial discomfort with heart palpitations and dizziness with no known cause.Unstable angina was diagnosed and the patient was hospitalized and medication was provided.The event resolved.On (b)(6) 2016, the patient experienced heart palpitations and lower limb weakness with no known cause.Unstable angina was diagnosed.The patient was hospitalized and medication was provided.The event resolved.Per physician, the events were unknown if related to the xience prime stent.There was no device malfunction.There was no additional information provided regarding this issue.(b)(6) 2014: creatine kinase muscle and brain (ck-mb)=13 ng/ml,normal upper limit 24 (b)(6) 2014: (ck)=150 u/l, normal upper limit 200 (b)(6) 2014: (ck-mb)=17 ng/ml, normal upper limit 24 (b)(6) 2014: troponin i=0.05 ng/ml, upper reference limit 0.4 (b)(6) 2014: electrocardiogram(ecg)=no myocardial infarction (b)(6) 2014: electrocardiogram(ecg)=no myocardial infarction (b)(6) 2014: electrocardiogram(ecg)=no myocardial infarction (b)(6) 2014: electrocardiogram(ecg)=no myocardial infarction (b)(6) 2014: (ck)=155 u/l, normal upper limit 170 (b)(6) 2014: (ck-mb)=8 ng/ml, normal upper limit 24 (b)(6) 2015: electrocardiogram(ecg)=no myocardial infarction (b)(6) 2015: ck-mb = 11 ng/ml, normal upper limit 24 (b)(6) 2015: ck = 186 u/l, normal upper limit 200 (b)(6) 2015: ck-mb = 11 u/l, normal upper limit 24 (b)(6) 2015: electrocardiogram(ecg)=no myocardial infarction (b)(6) 2015: ck = 311 u/l, normal upper limit 200 (b)(6) 2015: ck-mb = 14 ng/ml, normal upper limit 24 (b)(6) 2015: electrocardiogram(ecg)=no myocardial infarction (b)(6) 2015: ck = 153 u/l, normal upper limit 200 (b)(6) 2015: ck-mb = 9 ng/ml, normal upper limit 24 (b)(6) 2015: electrocardiogram(ecg)=no myocardial infarction (b)(6) 2015: ck = 177 u/l, normal upper limit 200 (b)(6) 2015: ck-mb = 15 ng/ml, normal upper limit 24 (b)(6) 2015: electrocardiogram(ecg)=no myocardial infarction (b)(6) 2015: electrocardiogram(ecg)=no myocardial infarction (b)(6) 2015: electrocardiogram(ecg)=no myocardial infarction (b)(6) 2016: electrocardiogram(ecg)=no myocardial infarction (b)(6) 2016: ck-mb = 0.85 ng/ml, normal upper limit 2.03 (b)(6) 2016: troponin i=0.012 ng/ml, upper reference limit 0.034 the device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.It should be noted that the reported patient effect of angina and arrhythmia are listed in the instructions for use xience prime everolimus eluting coronary stent systems as a known patient effect(s) of coronary stenting procedures.A conclusive cause for the reported patient effect(s) and the relationship to the product, if any, cannot be determined.However, the reported treatments appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that on (b)(6) 2013, a 3.5x18mm xience prime stent was successfully implanted in the distal right coronary artery (rca) lesion.The patient was discharged from the hospital on (b)(6) 2013.On (b)(6) 2014, the patient was hospitalized for sudden back pain and unstable angina was diagnosed.Medication was provided and the event resolved.On (b)(6) 2014, the patient experienced intermittent palpitations and unstable angina.The patient was hospitalized and medication was provided.The event resolved.On (b)(6) 2014, the patient experienced precordial discomfort with intermittent activity and unstable angina was diagnosed.The patient was hospitalized and medication was provided.The event resolved.On (b)(6) 2014 the patient experienced intermittent precordial discomfort and unstable angina was diagnosed.The patient had been hospitalized both times and medication was provided.The events resolved.On (b)(6) 2014, coronary angiography noted no stenosis in the xience prime stent.On (b)(6) 2015, the patient experienced intermittent precordial discomfort and unstable angina was diagnosed.The patient was hospitalized and medication was provided.The event resolved.

• Brand Name: XIENCE PRIME 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: 6671598
• MDR Text Key: 78542652
• Report Number: 2024168-2017-05431
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648123702
• UDI-Public: (01)08717648123702(17)190126(10)3011541
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2015
• Device Catalogue Number: 1011710-18
• Device Lot Number: 3011541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2013
• 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
• Patient Age: 53 YR
• Patient Weight: 73