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

Catalog Number	1550400-28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/10/2018
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.An investigation was not conducted because there were no specific reported device malfunctions nor any specified adverse event.There is no indication of a product quality issue with respect to design, manufacture or labeling.
Event or Problem Description
It was reported that on (b)(6) 2018, a 4.0x28mm xience sierra stent was implanted without reported issues.On (b)(6) 2018, the patient was admitted for gastritis and other cardiovascular symptoms.Endoscopy and percutaneous dilation of the superior mesenteric artery was performed.On (b)(6) 2018, the patient was admitted for gastritis and chronic vascular disorder of the intestine.The relationship to the device was not provided.No additional information was available regarding this event.

• 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: 8187393
• Report Number: 2024168-2018-09967
• Device Sequence Number: 1359224
• Product Code: NIQ
• UDI-Device Identifier: 08717648227523
• UDI-Public: 08717648227523
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/20/2018

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: 05/02/2019
• Device Catalogue Number: 1550400-28
• Device Lot Number: 8042641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 12/20/2018
• 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
• Patient Age: 75 YR
• Patient Weight: 45