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

Catalog Number	1074225-28
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	10/26/2015
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.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Stenosis is listed in the xience xpedition everolimus eluting coronary stent systems instructions for use, as a known patient effect of coronary stenting procedures.Based on the case information and related record review, a conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined and there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that on (b)(6) 2015 the 2.25x28 mm xience xpedition stent was implanted in the mid left anterior descending coronary artery (lad) and the 3.5x38mm xience alpine stent was implanted in the proximal lad.At the eight-month follow-up visit on (b)(6) 2015, restenosis was found in the non-target lesion (no xience stent was implanted) via coronary angiography.The patient underwent percutaneous coronary intervention on (b)(6) 2015 and a drug eluting stent was implanted in the mid lad.At the one year-follow-up, on (b)(6) 2016, the patient was noted to have hepatocellular carcinoma since (b)(6) 2015.In (b)(6) 2016, the patient died from hepatocellular carcinoma.No additional information was provided.

• 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: 6450966
• Report Number: 2024168-2017-02723
• Device Sequence Number: 13606740
• Product Code: NIQ
• UDI-Device Identifier: 08717648162060
• UDI-Public: (01)08717648162060(17)160707(10)4063042
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/31/2017

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: 07/07/2016
• Device Catalogue Number: 1074225-28
• Device Lot Number: 4063042
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2017
• Initial Report FDA Received Date: 03/31/2017
• 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: 3.5X38 MM XIENCE ALPINE STENTASPIRIN, CLOPIDOGRE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 59