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

Catalog Number 1125300-08

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

Patient Problems Thrombosis (2100); Cardiogenic Shock (2262)

Event Date 12/13/2017

Event Type  Injury  

Manufacturer Narrative

The patient and device codes were coded by the manufacturer.(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 thrombosis and shock 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 effect(s), 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 other 4 xience alpine devices referenced are filed under separate medwatch report numbers.

Event Description

It was reported that the procedure was to treat the left anterior descending (lad) artery and the right coronary artery (rca).The patient presented with an st elevated myocardial infarction (stemi).Two xience alpines stents (2.75 x 23 mm and 3.0 x 08 mm) were implanted in the lad and three xience alpine stents were implanted in the rca.The patient was given angiomax.The procedure went well; however, when being taken to the intensive care unit (icu), the patient went into cardiogenic shock.The patient was taken back to the cath lab where an intra-aortic balloon pump was put in and then thrombosis was observed in all five stents.The thrombosis in the proximal lad and the rca was treated with balloon angioplasty and the mid lad was treated with two non-abbott stents.The patients medication was changed to integrilin and is now stable.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: 7169120
• MDR Text Key: 96542311
• Report Number: 2024168-2018-00112
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648199325
• UDI-Public: 08717648199325
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2019
• Device Catalogue Number: 1125300-08
• Device Lot Number: 6010641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2016
• 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: STENT: 4 XIENCE ALPINE
• Patient Outcome(s): Life Threatening; Required Intervention