MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Model Number	1550275-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	High Blood Pressure/ Hypertension (1908)
Date of Event	08/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The two additional devices referenced are filed under separate medwatch report numbers.
Event or Problem Description
It was reported that on (b)(6) 2020, three xience sierra stents were successfully implanted (2.75x12mm, 3.0x12mm, 3.25x33mm).On (b)(6) 2020, the patient was re-admitted with hypertension and other cardiovascular symptoms.It is unknown what treatment was performed and the final patient outcome is unknown.No additional information was provided.
Additional Manufacturer Narrative
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 effect of hypertension 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.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined; however, the reported treatments appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.D6: implant date.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10977773
• Report Number: 2024168-2020-10334
• Device Sequence Number: 14526923
• Product Code: NIQ
• UDI-Device Identifier: 08717648227165
• UDI-Public: 08717648227165
• Combination Product (Y/N): Y
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2021

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: 03/05/2021
• Device Model Number: 1550275-12
• Device Catalogue Number: 1550275-12
• Device Lot Number: 0022841
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 01/18/2021
• 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: XIENCE SIERRA DES 3.00X12 RX US; XIENCE SIERRA DES 3.25X33 RX US; XIENCE SIERRA DES 3.00X12 RX US; XIENCE SIERRA DES 3.25X33 RX US
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 71 YR
• Patient Weight: 87