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

Catalog Number 1074350-12

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

Patient Problems Angina (1710); Ischemia (1942); Stenosis (2263); Test Result (2695)

Event Date 06/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).The device remains implanted in the anatomy.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that on (b)(6) 2013, a 4.0x18mm and two 3.5x12mm xience xpedition stents were successfully implanted in the left main (lm) to proximal circumflex (cx) coronary arteries.A 3.5x12mm xience xpedition stent was successfully implanted in the mid left anterior descending (lad) coronary artery.On (b)(6) 2017, a positive dobutamine stress test indicated ischemia with slow blood flow.On (b)(6) 2017, the patient was hospitalized and diagnostic imaging was performed.Although coronary artery stenosis was noted in the mid lad 3.5x12mm xience xpedition stent, percutaneous intervention was performed in another mid lad de novo lesion, not within 5mm of the previous mid lad stent.Cardiac medications were provided and aspirin was restarted.The event resolved.There was no additional information provided regarding this issue.

Manufacturer Narrative

Internal file number - (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.The reported patient effects of angina, ischemia, and stenosis are listed in the xience xpedition, xience xpedition everolimus eluting coronary stent systems instructions for use (ifu) as known patient effects of coronary stenting procedures.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

Subsequent to the initial report, additional information was received: during the (b)(6) 2017 hospitalization, another percutaneous intervention was performed at the mid left anterior descending coronary artery 3.5x12mm xience xpedition stent target lesion site.The event resolved without sequela.

• Brand Name: XIENCE XPEDITION 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: 7045737
• MDR Text Key: 92528333
• Report Number: 2024168-2017-09082
• 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,Followup
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2014
• Device Catalogue Number: 1074350-12
• Device Lot Number: 3053042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• 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: 3 IMPLANTED XIENCE XPEDITION STENTS
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 121