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

Catalog Number	1125400-12
Health Effect - Clinical Codes	Death (1802); Sepsis (2067)
Date of Event	09/16/2017
Type of Reportable Event	Death
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.The reported patient effect of death is listed in the xience alpine everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.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 manufacture, design or labeling.
Event or Problem Description
It was reported that the index procedure took place on (b)(6) 2017 during which a 4.0 x 12 mm xience alpine stent was implanted for treatment of an unspecified vessel.The patient was readmitted to the hospital on (b)(6) 2017 for sepsis and other unspecified cardiac vascular symptoms.Unspecified treatment was administered to the patient.Final patient outcome is death.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Subsequent to the initial report, additional information has been received.A 5.0 x 13 mm ultra 9-cell stent was implanted for treatment of an unspecified vessel as well.No additional information was provided.
Additional Manufacturer Narrative
Internal file number - (b)(4).Event description revised to include a 5.0x13mm ultra stent.The correct date for the follow-up mdr submitted on 02/02/2018 is 02/02/2018.
Event or Problem Description
Updated for clarity to include reference to the ultra stent.In the initial mdr, the 5.0x13mm ultra stent was listed ; however, it was not included in the event description.Case details revised: during the index procedure on (b)(6) 2017 to treat an unspecified vessel, a 4.0x12mm xience alpine stent and a 5.0x13mm ultra stent were both implanted.Patient developed sepsis and passed away.

• Brand Name: XIENCE ALPINE 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: 7082665
• Report Number: 2024168-2017-09394
• Device Sequence Number: 19206239
• Product Code: NIQ
• UDI-Device Identifier: 08717648199608
• UDI-Public: 08717648199608
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/15/2018

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: 07/03/2020
• Device Catalogue Number: 1125400-12
• Device Lot Number: 7062641
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2017
• Supplement Date Received by Manufacturer: 11/17/2017; 02/13/2018
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 02/02/2018; 02/15/2018
• 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: STENT: 5.0 X 13 MM ULTRA 9-CELL
• Outcome Attributed to Adverse Event: Death
• Patient Age: 68 YR
• Patient Weight: 103