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

Catalog Number 1120300-15

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Atrial Fibrillation (1729); Myocardial Infarction (1969); Thrombosis (2100)

Event Date 05/17/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2019, a 3.0x15mm xience alpine stent was successfully implanted proximal right coronary artery (rca).On (b)(6) 2019, the patient was hospitalized for angina.The patient was in atrial fibrillation and an st elevated myocardial infarction (stemi) was diagnosed.That same day, proximal rca stent thrombosis was observed.As treatment, another percutaneous intervention (revascularization) was performed in the proximal rca.Per physician, there was no device malfunction.No additional information was provided regarding this issue.

Manufacturer Narrative

Internal file number: (b)(4).

Manufacturer Narrative

Internal file number - (b)(4).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 effect(s) of angina, atrial fibrillation, myocardial infarction, and thrombosis are listed in the xience alpine everolimus eluting coronary stent systems instructions for use as a known patient effect(s) 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 treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8671630
• MDR Text Key: 147088039
• Report Number: 2024168-2019-04444
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2021
• Device Catalogue Number: 1120300-15
• Device Lot Number: 8012341
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 63 YR
• Patient Weight: 73