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

Catalog Number	1074300-38
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	08/02/2018
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.Implant date has been estimated.The device was not returned for evaluation.A review of the lot history record could not be performed as the lot number was not provided.The reported patient effect of stenosis is listed in the xience xpedition, ce eluting coronary stent systems (eccs) instructions for use, as a known patient effect.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.The additional xience xpedition device is being file under a separate medwatch report.
Event or Problem Description
It was reported that in (b)(6) 2018, the procedure was performed using two xience xpedition stents to treat a lesion in the mid right coronary artery (rca) with mild calcification.A 3.0 x 38 mm xience xpedition stent was implanted in the proximal rca and a 3.0 x 18 mm xience xpedition stent was implanted in the mid rca.On (b)(6) 2018, the patient presented with acute coronary syndrome from a de novo blockage.Angiography revealed the stents had 70-80% restenosis in the rca in both xience xpedition stents.Balloon angioplasty was performed to treat the restenosis.Per the physician, the cause of the restenosis was under expansion of the stent.The left anterior artery was also treated.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: 7819670
• Report Number: 2024168-2018-06620
• Device Sequence Number: 16596435
• Product Code: NIQ
• UDI-Device Identifier: 08717648162381
• UDI-Public: 08717648162381
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/27/2018

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 Catalogue Number: 1074300-38
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 08/27/2018
• 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: STENT: XIENCE XPEDITION
• Outcome Attributed to Adverse Event: Required Intervention