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

Catalog Number	1550225-28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Thrombosis (2100)
Date of Event	11/06/2018
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 incident information was reviewed; however, there was no reported device malfunction and the product was not returned as the stent remains in the anatomy.The reported patient effect of angina and thrombosis are listed in the xience sierra everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.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.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
Event or Problem Description
It was reported that on (b)(6) 2018, a procedure was performed to treat the bifurcation of the left anterior descending (lad) and 1st diagonal coronary arteries.The lesion was pre-dilated and a 2.25 x 28 mm xience sierra was successfully deployed at 11 atmospheres in the diagonal artery.Post dilatation was performed at 12 atmospheres at the lad for diagonal stent crushing.Intravascular ultrasound confirmed revascularization with excellent results.The patient was prescribed anticoagulant therapy.On (b)(6) 2018 the patient was re-admitted with angina and chest pain.Stent occlusion and early stent thrombosis were confirmed.The vessel was re-vascularized by aspirating the thrombus and further balloon angioplasty of the diagonal artery.The patient was prescribed anticoagulant therapy again and was reported to be 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: 8102611
• Report Number: 2024168-2018-09030
• Device Sequence Number: 19165702
• Product Code: NIQ
• UDI-Device Identifier: 08717648227042
• UDI-Public: 08717648227042
• Combination Product (Y/N): N
• 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): 11/26/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/22/2019
• Device Catalogue Number: 1550225-28
• Device Lot Number: 8081041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 11/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR