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

Model Number	1125300-18
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Intimal Dissection (1333); Angina (1710); Dyspnea (1816); Fatigue (1849); Stenosis (2263)
Date of Event	08/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2019001.The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
Patient id: (b)(6).It was reported that on (b)(6) 2018, a 3.0x18mm (1125300-18, 8021261) xience alpine stent was implanted in the mid left anterior descending (lad) coronary artery lesion.Stent malposition and a proximal edge dissection was observed.Additional post-dilatation was performed as treatment.Reportedly, following the additional post-dilatation (using the maximum balloon size and maximum pressure), there remained sub-optimal, distal stent expansion.No additional treatment was provided.On (b)(6) 2019, the patient was hospitalized for increasing dyspnea, chest tightness/pain, and fatigue.Another cardiac catheterization was performed and lad in-stent restenosis was observed along with severe three vessel disease.On (b)(6) 2019, a coronary artery bypass surgery was performed as treatment.No additional information was provided regarding this issue.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported patient-device incompatibility/difficult to deploy (wall apposition); however, the subsequent treatments appear to be related to the operational context of the procedure.It should be noted that the reported patient effects of angina, dyspnea, fatigue, intimal dissection and stenosis are listed in the xience alpine, everolimus eluting coronary stent system instructions for use (ifu) 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.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

• Brand Name: XIENCE ALPINE
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9560331
• Report Number: 2024168-2020-00443
• Device Sequence Number: 16737979
• Product Code: NIQ
• UDI-Device Identifier: 08717648199356
• UDI-Public: 08717648199356
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/25/2021
• Device Model Number: 1125300-18
• Device Catalogue Number: 1125300-18
• Device Lot Number: 8021261
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 02/05/2020
• 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: 5FR; ASPIRIN, PRASUGREL
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 61 YR
• Patient Weight: 113