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

Catalog Number 1011709-18

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

Patient Problem Intimal Dissection (1333)

Event Date 11/18/2016

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 effect, and the relationship to the product, if any, cannot be determined; however the reported treatments appear to be related to circumstances of the procedure.The reported patient effect of dissection is listed in the xience prime everolimus eluting coronary stent system instructions for use as a known patient effect of coronary stenting procedures.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat an 85% stenosed, mildly tortuous, and moderately calcified de novo lesion in the distal left anterior descending artery.The patient presented with angina.Pre-dilatation was performed with a semi compliant balloon and a 3.0x18mm xience prime stent was implanted; however, post stenting showed an edge dissection.The dissection was successfully covered using another 3.0x18mm xience prime stent delivery system.There was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: XIENCE PRIME 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: 6215943
• MDR Text Key: 63655354
• Report Number: 2024168-2016-09402
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648123627
• UDI-Public: (01)08717648123627(17)181118(10)5111241
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2018
• Device Catalogue Number: 1011709-18
• Device Lot Number: 5111241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2015
• 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
• Patient Outcome(s): Required Intervention