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

Catalog Number 1125400-08

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

Patient Problem Sepsis (2067)

Event Date 10/03/2017

Event Type  Injury  

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.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

It was reported that a 4.0 x 8 mm xience alpine stent was implanted on (b)(6) 2017.On (b)(6) 2017, the patient was re-admitted with cardiovascular symptoms including sepsis.Although the treatment performed is unspecified, the fact that rehospitalization occurred indicates that some form of treatment was performed.The final patient outcome is unknown.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: 7088659
• MDR Text Key: 94055556
• Report Number: 2024168-2017-09457
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648199592
• UDI-Public: 08717648199592
• 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
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/06/2017

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: 03/29/2020
• Device Catalogue Number: 1125400-08
• Device Lot Number: 7032141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2017
• Initial Date FDA Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 145