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

Model Number	1074300-23
Health Effect - Clinical Codes	Cardiac Enzyme Elevation (1838); Ischemia (1942); Stenosis (2263)
Date of Event	06/06/2016
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 and complaint history of the reported lot could not be conducted because the lot number was not provided.Ischemia and stenosis are listed in the xience xpedition everolimus eluting coronary stent systems instructions for use as known patient effects 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 on (b)(6) 2013 one 2.25x23 xience prime stent was implanted in the posterior-lateral coronary (pl) artery and one 3.0x23 xience xpedition stent was implanted in the obtuse marginal (om) coronary artery.At the third year follow up visit, (b)(6) 2016, the patient had a positive ischemia function test, which was supposedly caused by the target vessel.On (b)(6) 2016, in-stent restenosis was confirmed in the om and the patient was hospitalized.Surgery was performed and grafts were placed in the om, distal left anterior descending coronary artery, and the posterior descending coronary artery.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Subsequent to the previously filed report, additional information was received that there was no restenosis in the obtuse marginal xience xpedition stent.The previous report of restenosis in this stent was incorrect.No investigation required.
Event or Problem Description
Subsequent to the previously filed report, additional information was received that there was no restenosis in the obtuse marginal xience xpedition stent.The previous report of restenosis in this stent was incorrect.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: 6295039
• Report Number: 2024168-2017-00870
• Device Sequence Number: 16262081
• Product Code: NIQ
• UDI-Device Identifier: 08717648162350
• UDI-Public: (01)08717648162350
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2018

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 Model Number: 1074300-23
• Device Catalogue Number: 1074300-23
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2017
• Supplement Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 02/01/2017
• Supplement Report FDA Received Date: 01/12/2018
• 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: 2.25X23 XIENCE PRIME STENT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 72 YR
• Patient Weight: 67