MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE XPEDITION; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number	1074275-38
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Myocardial Infarction (1969); Stenosis (2263)
Date of Event	09/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no reported device malfunction and the product was not returned as the stent remains in the anatomy.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 effects, and the relationship to the product, if any, cannot be determined.The reported patient effects of angina, restenosis and myocardial infarction are listed in the xience xpedition, everolimus eluting coronary stent system (eecss), instructions for use as known patient effects of coronary stenting procedures.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The 2.5x38 mm xience xpedition stent is being filed under a separate medwatch report #.
Event or Problem Description
It was reported that on (b)(6) 2019 two xience xpedition stents, sizes 2.75x38 and 2.5x38 mm, were implanted in the chronic total occlusion in the left anterior descending coronary artery; one was implanted in the proximal to mid lad, the other was implanted in the distal lad.On (b)(6) 2019 the patient had chest pain and was found to have a non st elevation myocardial infarction.There was in-stent restenosis in the proximal to mid lad.This was treated with a non-abbott drug eluting stent.In the distal lad, the stent was fractured.The distal stent was located in an area with a large amount of movement because it is at a bend.The distal stent was patent and did not require any treatment.The patient condition resolved and the patient was discharged home on 9/10/2019.No additional information was provided.

• Brand Name: XIENCE XPEDITION
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9130951
• Report Number: 2024168-2019-12172
• Device Sequence Number: 1984065
• Product Code: NIQ
• UDI-Device Identifier: 08717648162282
• UDI-Public: 08717648162282
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/10/2022
• Device Catalogue Number: 1074275-38
• Device Lot Number: 9030541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 09/27/2019
• 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: 2.50X38 MM XIENCE XPEDITION STENT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 88 YR
• Patient Weight: 73