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

Model Number	1074350-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Myocardial Infarction (1969)
Date of Event	10/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 effects of angina and myocardial infarction are listed in the xience xpedition, everolimus eluting coronary stent system, instructions for use, as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
Event or Problem Description
Patient id: (b)(6).It was reported that on (b)(6) /2019, the patient presented with elevated cardiac enzymes and a percutaneous coronary intervention (pci) was performed.Pre-dilatation was performed on the proximal right coronary artery (rca), 100% stenosed lesion and a 3.5x23mm (1074350-23 9053141) xience xpedition stent was successfully implanted.Pre-dilatation was also performed on the mid circumflex (cx) coronary artery, 100% stenosed lesion and a 2.5x28mm (1074250-28 9031141) xience xpedition stent was successfully implanted.Reportedly excellent results were observed with 0% diameter stenosis, timi flow iii, and no complications.Post-procedure, the patient experienced chest pain, cardiac enzymes remained elevated and a new myocardial infarction was diagnosed.Medication was provided as treatment.Per physician, the event was unknown if device related.There was no device malfunction.No additional treatment was provided.The event was considered resolved on (b)(6) 2019.No additional information was provided regarding this issue.

• 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: 9655788
• Report Number: 2024168-2020-01105
• Device Sequence Number: 19539308
• Product Code: NIQ
• UDI-Device Identifier: 08717648162558
• UDI-Public: 08717648162558
• 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: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/31/2020

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: 06/09/2022
• Device Model Number: 1074350-23
• Device Catalogue Number: 1074350-23
• Device Lot Number: 9053141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 01/31/2020
• 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: Required Intervention; Disability
• Patient Age: 56 YR
• Patient Weight: 90