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

Catalog Number 1125225-12

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

Patient Problems Dyspnea (1816); Fatigue (1849); Hypersensitivity/Allergic reaction (1907)

Event Date 10/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event has been estimated.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 dyspnea, fatigue, and hypersensitivity are listed in the xience alpine everolimus eluting coronary stent system, instructions for use as known patient effects.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.The other 3.50 x 18mm xience alpine referenced is being filed under a separate medwatch report number.

Event Description

On (b)(6) 2017, a 2.25 x 12mm xience alpine was implanted in the proximal circumflex artery and a 3.50 x 18mm xience alpine was implanted in the mid right coronary artery.The next day after the procedure, the patient experienced a rash on her torso, treatment was not provided at the time.Additionally, two days later, the patient started experiencing breathing issues (couldn't breathe properly), and excessive yawning.In (b)(6) 2017, the patient went to the hospital to get checked for the shortness of breath and rash on her torso.Patient was given two advil tablets.Physician noted no complications or adverse effects on the patient.The patient left the same day.In (b)(6) 2018, the patient visited the hospital for another check-up and was given a stress test.Per the physician, the stress test result was normal.The patient left the same day.In (b)(6) 2018, the patient opted for a new physician.The rash remains the same and has not worsened.No additional information was provided.

Manufacturer Narrative

(b)(4).Date of event changed from (b)(6) 2018 to (b)(6) 2017.

• 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: 7639750
• MDR Text Key: 112415828
• Report Number: 2024168-2018-05050
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648199066
• UDI-Public: 08717648199066
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2020
• Device Catalogue Number: 1125225-12
• Device Lot Number: 7081041
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 68