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

Catalog Number 1125400-12

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

Patient Problems Angina (1710); Perforation (2001); Pseudoaneurysm (2605)

Event Date 10/19/2015

Event Type  Injury  

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.Angina, perforation and pseudoaneurysm are listed in the xience alpine everolimus eluting coronary stent systems instructions for use as a known patient effects of coronary stenting procedures.Although a relationship between the reported patient effects and the device, if any, cannot be determined, there is no indication of a product quality issue with respect to manufacture, design, or labeling.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The 3.5x33mm xience alpine referenced is being filed under a separate medwatch mfr number.

Event Description

It was reported that during a previous procedure on (b)(6) 2015 the patient was treated with the placement of four xience alpine stents in the right coronary artery (rca).Two of the xience alpine stents (4.0 x 12 mm and 3.5 x 33 mm) were deployed in the ostial and proximal rca.After post-dilatation of the deployed stents with high pressure, non-compliant balloons a limited extravasation was observed just outside the rca; however, echocardiography was performed and there was no blood noted in the pericardium; therefore, the patient was observed in the critical care unit and then discharged to home.On (b)(6) 2016 the patient began experiencing vague chest discomfort and angiography revealed that the extravasation that was observed during the first procedure had in fact been a perforation.The perforation led to the formation of a proximal rca pseudoaneurysm measuring up to 10-12 mm in diameter.The 4.0 x 26 mm graftmaster covered stent was used successfully to treat the pseudoaneurysm in the rca with no further filling of the pseudoaneurysm noted.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: 5497277
• MDR Text Key: 40223154
• Report Number: 2024168-2016-01567
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/11/2016

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: 06/02/2018
• Device Catalogue Number: 1125400-12
• Device Lot Number: 5052541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2016
• Initial Date FDA Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• 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: STENT: XIENCE ALPINE (3.5X28M, 3.5X38MM, 3.5X33MM)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR