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

Catalog Number UNK XIENCE SIERRA

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

Patient Problems Myocardial Infarction (1969); Heart Failure (2206)

Event Date 06/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat the left anterior descending artery.Some unspecified stents were implanted in 2005.The patient then presented with unstable angina on (b)(6) 2018.Therefore, an intravascular ultrasound (ivus) was performed and 2 unspecified xience sierra stents were implanted.One stent was implanted proximal to the original stent that was implanted in 2005, and the other xience sierra stent was implanted distally to the original stent implanted in 2005.Medication was also administered to the patient as it was suspected that they had a reaction to the brilinta medication.They were then given plavix instead.However, there was no platelet inhibition and the patient experienced a segment elevated myocardial infarction (stemi) and heart failure on (b)(6) 2018.Therefore, on (b)(6) 2018 and (b)(6) 2018, three unspecified xience sierra stents were implanted, and the patient was stable.There was no adverse patient sequela reported.No additional information was provided.

Manufacturer Narrative

(b)(4).In the absence of reported part number, udi cannot be calculated.The device was not returned for evaluation.A review of the lot history record could not be performed as the part and lot number were not provided.The reported patient effects of myocardial infarction is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect(s) and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: XIENCE SIERRA 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): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; 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: 7706142
• MDR Text Key: 114568988
• Report Number: 2024168-2018-05654
• 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: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/04/2018

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 Catalogue Number: UNK XIENCE SIERRA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2018
• Initial Date FDA Received: 07/20/2018
• Supplement Dates Manufacturer Received: 08/29/2018
• Supplement Dates FDA Received: 09/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: UNKNOWN XIENCE SIERRA
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 50 YR