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

Catalog Number	1074350-18
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	04/18/2017
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.Concomitant medical products: stent: xience xpedition 2.25x18mm; medication: aspirin 100mg/day [stopped on (b)(6) 2018], clopidogrel 75mg/day.The stent remains in the patient and there was no reported device malfunction.The reported patient effect of stenosis is listed in the xience xpedition instructions, as a known patient effect.A review of the lot history record could not be performed as no lot number was provided.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 the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that on (b)(6) 2015 the 3.5x18mm xience xpedition stent was implanted in the 13mm, vessel diameter 3.5mm, 75% stenosis in the mid left anterior descending coronary artery (lad) and the 2.25x18 mm xience xpedition stent was implanted in the atrio-ventricular (av) artery.On 04/18/2017, 75% in-stent restenosis (isr) was found in the mid lad.On (b)(6) 2017, percutaneous revascularization was performed with a drug eluting stent in the mid lad.The condition resolved on (b)(6) 2017.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Correction: implant date updated from (b)(6) 2015 to (b)(6) 2015.
Event or Problem Description
Subsequent to the previously filed report, additional information was received that the xience xpedition was implanted on (b)(6) 2015.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: 7674273
• Report Number: 2024168-2018-05199
• Device Sequence Number: 16489845
• Product Code: NIQ
• UDI-Device Identifier: 08717648162541
• UDI-Public: 08717648162541
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2019

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 Catalogue Number: 1074350-18
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2018
• Supplement Date Received by Manufacturer: 04/22/2019
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 66