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

Catalog Number	1074225-28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	06/24/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).(b)(6).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 xpedition everolimus eluting coronary stent systems instructions for use 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.There is no indication of a product quality issue with respect to manufacture, design or labeling.The 2.25 x 28 mm xience xpedition stent restenosis event was filed under a separate manufacturer report number.
Event or Problem Description
It was reported that on (b)(6) 2014, a 2.25x28mm xience xpedition was placed atrioventricular in the right coronary artery (rca) to treat a dissection, a 2.5x38 mm xience xpedition stent was implanted in the distal rca, and a 3.0x23 mm xience xpedition stent was implanted in the proximal rca to treat a dissection.On an unknown date, estimated as (b)(6) 2015, 100% restenosis was noted in the atrioventricular rca where the 2.25 x 28 mm xience was implanted.The restenosis was not treated as the patient had no symptoms.On (b)(6) 2017, the patient had been admitted to the hospital for pneumonia and the patient expired.Per physician, the cause of death is not known and the relationship to the device is unknown.No additional information was provided regarding this issue.

• Brand Name: XIENCE XPEDITION 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: 7659951
• Report Number: 2024168-2018-05135
• Device Sequence Number: 2012077
• Product Code: NIQ
• UDI-Device Identifier: 08717648162060
• UDI-Public: 08717648162060
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/03/2018

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: 05/18/2016
• Device Catalogue Number: 1074225-28
• Device Lot Number: 4051041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 07/03/2018
• 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: XIENCE XPEDITION STENTS (X2)
• Outcome Attributed to Adverse Event: Death
• Patient Age: 69 YR
• Patient Weight: 63