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

Catalog Number	1550325-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	12/31/2018
Type of Reportable Event	Serious Injury
Additional 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.A conclusive cause for the reported patient effect(s) and the relationship to the product, if any, cannot be determined; however, the subsequent treatments appear to be related to the circumstances of the procedure.The reported patient effect of thrombosis is listed in the xience sierra, everolimus eluting coronary stent system (eecss) instructions for use (ifu) as a known patient effect of coronary stenting procedures.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.The other two xience sierra devices referenced are filed under separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the left anterior descending (lad) coronary artery.During the procedure, three xience sierra stents (2.5 x 38mm 3.0 x 15mm, and 3.25 x 23mm), were deployed; however, thrombosis was noted on all three stents.There were no device issues and the stents were well-apposed to the vessel wall.Aspiration was performed to remove the clots and the patient was given medication.The procedure went well.The patient remained on medication and was stable.No additional information was provided.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8226619
• Report Number: 2024168-2019-00157
• Device Sequence Number: 1827513
• Product Code: NIQ
• UDI-Device Identifier: 08717648227356
• UDI-Public: 08717648227356
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/24/2019
• Device Catalogue Number: 1550325-23
• Device Lot Number: 8061341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2018
• Initial Report FDA Received Date: 01/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.5 X 38MM AND 3.0 X 15MM XIENCE SIERRA STENTS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR