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

Catalog Number 1120300-18

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

Patient Problems Fever (1858); Hypersensitivity/Allergic reaction (1907)

Event Date 11/11/2017

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 fever and hypersensitivity are listed in the xience alpine everolimus eluting coronary stent systems instructions for use as known patient effects 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.The 3.00 x 33 mm xience alpine referenced in describe event or problem and concomitant medical products is filed under a separate medwatch report.

Event Description

It was reported that a 3.00 x 18 mm xience alpine stent and a 3.00 x 33 mm xience alpine stent were implanted on (b)(6) 2017.On (b)(6) 2017 the patient presented at the emergency room with a fever of unknown origin that began on (b)(6) 2017.The patient was hospitalized from (b)(6) 2017.The patient's body temperature during hospitalization ranged between 103.28 degrees 98.78 degrees.Several tests were run and white blood cell (wbc) was low.The patient was treated with antibiotic for 5 days, and other medications; aspirin, bisoprolol, pitavastatin, clopidogrel.The patient still had a fever.On (b)(6) 2017, the patient was transferred to another hospital at their request for treatment.On (b)(6) 2017 the patient was seen in the out-patient department and was still complaining of a fever.On (b)(6) 2017 the patient was seen again in the out-patient department and was no longer complaining of a fever.The physician speculated that the patient's fever may have been caused by the drug eluting from the xience alpine stents and after a month there was no more drug eluting from the stents.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: 7267674
• MDR Text Key: 99950520
• Report Number: 2024168-2018-01052
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2020
• Device Catalogue Number: 1120300-18
• Device Lot Number: 7072241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2017
• 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
• Treatment: THE 3.00 X 33 MM XIENCE ALPINE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR