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

Catalog Number 1011711-15

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

Patient Problems Angina (1710); Edema (1820); Cardiac Enzyme Elevation (1838)

Event Date 07/02/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(6) 2014: ck=96 u/l, normal upper limit 195; (b)(6) 2014: ck-mb=16.0 u/l, normal upper limit 25; (b)(6) 2014: troponin i=2.30 ng/ml, upper reference limit 1.7; (b)(6) 2015: ck=175 u/l, normal upper limit 195; (b)(6) 2015: ck-mb=18.3 u/l, normal upper limit 25; (b)(6) 2015: troponin i=0.96 ng/ml, upper reference limit 1.7.There was no reported device malfunction and the product was not returned.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 effect of angina and edema are listed in the instructions for use xience prime everolimus eluting coronary stent systems 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 and there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

Event Description

It was reported that on (b)(6) 2014, the patient underwent a coronary stenting procedure with implantation of a 4.0 x 15 mm xience prime stent in the left main coronary artery.On (b)(6) 2014, the patient began to experience chest tightness and was re-hospitalized.Medication was administered.The chest tightness resolved on (b)(6) 2014.On (b)(6) 2014, the patient began to experience chest tightness and was re-hospitalized.Cardiac enzymes were elevated.Medication was administered and the event resolved on (b)(6) 2014.On (b)(6) 2015, the patient was re-hospitalized with edema in the lower limbs.Medication was administered and the event resolved on (b)(6) 2015.No additional information was requested.

• 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: 6673811
• MDR Text Key: 78601653
• Report Number: 2024168-2017-05469
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648123771
• UDI-Public: (01)08717648123771(17)150501(10)3041841
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2015
• Device Catalogue Number: 1011711-15
• Device Lot Number: 3041841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 45