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

Catalog Number	1074325-18
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	01/19/2017
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.Article authors: dr.Suzuki, hiroshi, dr.Sone, hiromoto, et al.Published on page 162 of the 31st congress of japanese coronary association.The device was not returned for evaluation.The reported patient effect of stenosis is listed in the xience xpedition, everolimus eluting coronary stent system, instructions for use as a known patient effect of coronary stenting procedures.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.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 of the device.
Event or Problem Description
The following information was reported from an article titled: `different outcomes of the two xience stent implants deployed in the same branches of coronary confirmed by ofdi.' in (b)(6) 2014, the patient underwent a cardiac ultrasound which revealed an inferior old myocardial infarction.It was reported that on (b)(6) 2014, a procedure was performed to treat a lesion in the first marginal branch of the left circumflex coronary artery (lcx) with 90% stenosis.A 3.0x23 mm xience xpedition stent was deployed and revascularization was confirmed.Post procedure, an acute stent thrombosis was suspected with st elevation.Coronary angiography confirmed a thrombus in the distal lcx not within 5mm of the deployed 3.0x23 mm xience xpedition in the first marginal branch.A 3.25x18 mm xience xpedition stent was deployed to treat the lesion in the distal lcx and the patient was put on dual antiplatelet therapy following.On (b)(6) 2017, a computed tomography scan confirmed 99% re-stenosis in the 3.25x18 mm xience xpedition stent.In (b)(6) 2017, the patient underwent an unspecified percutaneous coronary intervention which confirmed that the 3.25x18 mm xience xpedition stent was sufficiently dilated, but proliferation of the heterogenous plaque had occurred.The patient recovered and was discharged on an unknown date.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: 7601639
• Report Number: 2024168-2018-04476
• Device Sequence Number: 10821068
• Product Code: NIQ
• UDI-Device Identifier: 08717648162442
• UDI-Public: 08717648162442
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/14/2018

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: 03/07/2015
• Device Catalogue Number: 1074325-18
• Device Lot Number: 3022241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 06/14/2018
• 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: 3.0X23 MM XIENCE XPEDITION STENT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 65