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

Catalog Number 1125350-18

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

Patient Problems Death (1802); Headache (1880); Intracranial Hemorrhage (1891); Dizziness (2194)

Event Date 12/12/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).There was no reported device malfunction and the product was not returned.The investigation was unable to determine a definitive cause for the patient effect.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.The reported patient effects of headache and death, as listed in the xience alpine everolimus eluting coronary stent system electronic instructions for use, are known patient effects that may be associated with use of a coronary stent in native coronary arteries.Although 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 manufacturing, design or labeling.

Event Description

It was reported that on (b)(6) 2015 the 3.5x18 xience alpine stent was implanted in the proximal right coronary artery.On (b)(6) 2015 the patient was seen in the emergency department with a headache and dizziness.The patient became unresponsive.Computed tomography showed a subarachnoid hemorrhage.Prasugrel was discontinued due to the hemorrhage.The patient was hospitalized and intubated for mechanical ventilation.The patient's status declined and the patient was unable to be removed from the ventilator.Hydrocephalus developed due to the hemorrhage.The patient's family decided to withdrawn medical care from the patient.The patient expired on (b)(6) 2015 with the primary cause of death being non-cardiovascular.An autopsy was not performed.No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: 5351103
• MDR Text Key: 35274473
• Report Number: 2024168-2016-00060
• 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: health professional,study
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2018
• Device Catalogue Number: 1125350-18
• Device Lot Number: 5072141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2015
• 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: OTHER: ASPIRIN, PRASUGREL
• Patient Outcome(s): Death
• Patient Age: 71 YR
• Patient Weight: 117