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

Catalog Number 1011734-18

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

Patient Problems Angina (1710); Atrial Fibrillation (1729)

Event Date 09/30/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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.The reported patient effects of angina and atrial fibrillation are listed in the xience prime everolimus eluting coronary stent system instructions for use (ifu), as known patient effects of coronary stenting procedures.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 and 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, the patient presented with unstable angina.A 3.5x18mm xience prime stent was successfully implanted in the proximal left anterior descending (lad) coronary artery lesion.On (b)(6) 2014, a follow-up coronary angiography was performed without any xience prime stent issue noted.On (b)(6) 2015, the patient was hospitalized due to chest pain and palpitations.Atrial fibrillation was diagnosed and intravenous (iv) medications were provided.The patients condition improved and the patient was discharged from the hospital.The next day, in the morning, the chest pain and palpitations were experienced again.The patient presented to the emergency room and medication was provided.The atrial fibrillation continued.Electro-cardioversion was performed as treatment and normal sinus rhythm followed.On (b)(6) 2015, the patient presented to the emergency room again with atrial fibrillation.Electro-cardioversion was performed.The atrial fibrillation continued.On (b)(6) 2015 percutaneous cardiac ablation was performed and the patients condition improved.Per physician, the relationship of the device to the cardiac arrhythmias is unclear.There was no additional information provided.

• 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: 6106219
• MDR Text Key: 60019535
• Report Number: 2024168-2016-07996
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648177231
• UDI-Public: (01)08717648177231(17)141017(10)2100441
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/16/2016

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 Expiration Date: 10/17/2014
• Device Catalogue Number: 1011734-18
• Device Lot Number: 2100441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2016
• Initial Date FDA Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• 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: 77 YR
• Patient Weight: 63