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

Catalog Number 1125300-23

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

Patient Problems Angina (1710); Death (1802); Dyspnea (1816); Myocardial Infarction (1969); Pulmonary Edema (2020)

Event Date 09/02/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).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 the procedure was performed to treat a lesion in the proximal circumflex artery with a 3.0 x 23 mm xience alpine stent.Approximately 3 months post stenting procedure, the patient had complaints of dyspnea and chest heaviness, diagnosed as pulmonary edema.Cardiac enzymes were elevated and myocardial infarction was diagnosed.Unspecified treatment was provided.Cardiac catheterization was performed.No additional information was provided.

Manufacturer Narrative

(b)(4).The reported patient effect of death is listed in instructions for use xience alpine everolimus eluting coronary stent systems as a known patient effect of coronary stenting procedures.A conclusive cause for the reported death and the relationship to the product, if any, cannot be determined; however, based on the information, the reported death is not related to the device, but is related to progression of disease.

Event Description

Subsequent to the follow-up # 1 medwatch report, the following information was provided: the patient was discharged to home on (b)(6) 2018, on hospice care, after hospitalization for myocardial infarction.On (b)(6) 2018, the patient died of causes related to progression of disease.Per the physician, the death is not related to the implanted stent.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 effects of angina, dyspnea, myocardial infarction and pulmonary edema are listed in instructions for use xience alpine everolimus eluting coronary stent systems 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.

Event Description

Subsequent to the initial report, additional information was provided, which indicated that on (b)(6) 2018, the patient was re-hospitalized.Treatment for the pulmonary edema was dialysis.Cardiac catheterization was performed and a non-abbott stent was implanted.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: 7916986
• MDR Text Key: 121989511
• Report Number: 2024168-2018-07496
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2019

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: 01/31/2021
• Device Catalogue Number: 1125300-23
• Device Lot Number: 8012041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2018
• Initial Date FDA Received: 09/27/2018
• Supplement Dates Manufacturer Received: 10/01/2018; 01/28/2019
• Supplement Dates FDA Received: 10/04/2018; 02/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2018
• 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): Death; Hospitalization; Required Intervention; Disability
• Patient Age: 85 YR
• Patient Weight: 86