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

Catalog Number 1074300-38

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

Patient Problems Syncope (1610); Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Dizziness (2194); Diaphoresis (2452)

Event Date 09/01/2013

Event Type  Injury  

Event Description

It was reported that post-stenting procedure with 2 xience xpedition stents the patient experienced issues of blood pressure spikes, sleep disturbance, night sweats, dizziness when laying down at night, and in general not feeling well.It was noted that post stenting while in the hospital the patient stood up at the bedside and passed out/fainted; blood pressure was noted to be at 170/95 and the patient has recently starting taking atenolol.There was no additional information provided.

Manufacturer Narrative

(b)(4).Concomitant products: stent: xience xpedition ll.There was no reported device malfunction and the product was not returned.The reported patient effects of hypersensitivity and hypertension are known observed and potential patient effects as listed in the xience xpedition everolimus eluting coronary stent system instructions for use (ifu).Although 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 deficiency with respect to manufacturing, design or labeling.

• 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 462
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 3644337
• MDR Text Key: 4210313
• Report Number: 2024168-2014-01089
• 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,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/31/2014

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: 12/11/2013
• Device Catalogue Number: 1074300-38
• Device Lot Number: 2120341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2014
• Initial Date FDA Received: 02/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2012
• 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