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

Catalog Number 1011706-12

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

Patient Problems Angina (1710); Headache (1880); Dizziness (2194)

Event Date 03/14/2016

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.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that on (b)(6) 2013, the patient was admitted with paroxysmal chest pain of 10 years and exacerbated for one month.Coronary angiography was performed on (b)(6) 2013 and a 2.25 x 12 mm xience prime stent was implanted in the middle right coronary artery (rca).The patient was discharged on (b)(6) 2013.On (b)(6) 2016, the patient was re-hospitalized with a two-month history of chest pain, headache and dizziness.Medications were administered and the patient was discharged to home on (b)(6) 2016.No additional information was provided.

Manufacturer Narrative

(b)(4).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 effect of angina is listed in the xience prime small vessel (sv) everolimus eluting coronary stent system (eecss), instructions for use (ifu) as a known patient effect of coronary stenting procedures.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 manufacture, design or labeling of the device.

Manufacturer Narrative

(b)(4).The date was filed incorrectly on the initial medwatch report as (b)(4) 2017, but should have been (b)(4) 2017.

• Brand Name: XIENCE PRIME SV 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: 7188477
• MDR Text Key: 97341769
• Report Number: 2024168-2018-00357
• Device Sequence Number: 1
• Product Code: NIQ
• 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: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2018

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: 07/17/2016
• Device Catalogue Number: 1011706-12
• Device Lot Number: 3071041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/18/2017
• Initial Date FDA Received: 01/12/2018
• Supplement Dates Manufacturer Received: 01/15/2018; 02/15/2018
• Supplement Dates FDA Received: 01/19/2018; 02/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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: 67 YR