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

Catalog Number 1009528-28

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

Patient Problems Angina (1710); Cardiac Enzyme Elevation (1838); Headache (1880); Stenosis (2263)

Event Date 01/03/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.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, headache, and stenosis are listed in the xience v everolimus eluting coronary stent system instructions for use as known patient effects of coronary stenting procedures.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however the reported treatments appear to be related to circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The other device referenced is being filed under a separate medwatch report.

Event Description

It was reported that on (b)(6) 2011, the patient underwent a coronary stenting procedure with implantation of a 2.75 x 28 mm xience v stent in the proximal left anterior descending (lad) artery, a 2.75 x 28 mm xience v stent in the mid right coronary artery (rca) and a 2.5 x 23 mm xience v stent in the distal rca.On (b)(6) 2016, the patient began experiencing headaches with chest pain for about 1 month.On (b)(6) 2016, the patient was re-hospitalized with headache and chest pain.Troponin levels were elevated.Coronary angiography confirmed in-stent restenosis; however, a device malfunction, such as stent fracture or collapse, could not be confirmed.Intervention was performed on (b)(6) 2016 at the stent located in the mid rca.The patient condition resolved on (b)(6) 2016 and was discharged before echocardiography could be performed to see if a device issue occurred.No additional information was provided.

• Brand Name: XIENCE V 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: 6003659
• MDR Text Key: 56587849
• Report Number: 2024168-2016-06700
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648062681
• UDI-Public: (01)08717648062681(17)130202(10)1012441
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2013
• Device Catalogue Number: 1009528-28
• Device Lot Number: 1012441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2011
• 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 V 2.5X23; STENT: XIENCE V 2.5X23
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 62