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

Catalog Number	1074350-18
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	11/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 stenosis is listed in the xience xpedition everolimus eluting coronary stent system 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 and there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
Event or Problem Description
It was reported that on (b)(6) 2013, the patient presented with unstable angina.Following pre-dilatation, a 3.5x18mm xience xpedition stent was successfully implanted in the 90% stenosed distal right coronary artery (rca), 90% stenosed lesion.On (b)(6) 2013, it was discovered the patient was non-complaint with dual anti-platelet therapy (dapt) medications.On (b)(6) 2016, the patient discontinued clopidogrel due a thumb carpometacarpal arthritis surgical operation.On (b)(6) 2016, per coronary angiography, 75% restenosis in the 3.5x18mm xience xpedition stent was observed.The patients medications were adjusted.On (b)(6) 2016, the patient was hospitalized for an unspecified percutaneous intervention (pci).Elevated liver enzymes were noted and liver disease is suspected.The pci was postponed and the patients medications were adjusted.On (b)(6) 2016, the patient was discharged from the hospital.Per physician, the stenosis may be related to the implanted stent.There was no additional information provided regarding this device issue.
Additional Manufacturer Narrative
(b)(4).The reported patient effect of ischemia is listed in the xience xpedition everolimus eluting coronary stent system instructions for use (ifu) 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 and there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
Event or Problem Description
Subsequent to the initial 30-day medical device report, the following information was received: on (b)(6) 2016, the patient experienced silent ischemia.On (b)(6) 2017, the patient was hospitalized and on (b)(6) 2017, percutaneous coronary intervention was performed in the distal right coronary artery.The condition resolved and on (b)(6) 2017 the patient was discharged.There was no additional information 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: 6248256
• Report Number: 2024168-2017-00411
• Device Sequence Number: 13687579
• Product Code: NIQ
• UDI-Device Identifier: 08717648162541
• UDI-Public: (01)08717648162541(17)150827(10)3082141
• 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): 02/28/2017

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: 08/27/2015
• Device Catalogue Number: 1074350-18
• Device Lot Number: 3082141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2017
• Supplement Report FDA Received Date: 02/28/2017
• 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: ASPIRIN
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 75