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

Catalog Number 1125275-15

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

Patient Problems Angina (1710); Ischemia (1942); Vasoconstriction (2126); Stenosis (2263)

Event Date 05/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Description of problem or event: continued: pharmacotherapy was reinforced with an increased dose of calcium antagonist and nitric acid medications; however, the chest pain did not get better.In (b)(6) 2017, an acetylcholine provocation test was performed and coronary vasospasm was induced in the lad and rca.Strong vasospasm was induced in the stent gap of the distal lad and the blood flow was stopped.A 2.25x18mm non-abbott stent was deployed in the distal lad; however, the patients symptoms did not get better.No additional information was provided.The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional xience alpine device referenced is being filed under a separate medwatch report.The journal of ibaraki circulation society.

Event Description

It was reported through a research article identifying a 3.0x23mm and 2.75x15mm xience alpine that may be related to the following: angina, ischemia, vasoconstrictions, stenosis, and hospitalization.Details are listed in the article, titled: the journal of ibaraki circulation society.It was reported that the procedure was performed to treat a lesion in the mid to distal left anterior descending artery.In 2009, the patient presented with stable angina and a 2.5x18mm and a 2.25x18mm non-abbott stents were deployed in the mid left anterior descending artery (lad).Around (b)(6) 2016, the patient began feeling chest pain at rest in the morning.On (b)(6) 2016, coronary angiography was performed and in-stent restenosis was confirmed in the mid lad and at a de novo lesion in the distal lad.A 3.0x23mm xience alpine stent was deployed in the mid lad to treat the in-stent restenosis and a 2.75x15mm xience alpine stent was deployed in the distal lad; however, the chest pain did not get better.In (b)(6) 2017, coronary angiography was performed and 50% restenosis was confirmed in the proximal edge of the 2.75x15mm xience alpine stent in the distal lad.A fractional flow reserve test was performed and the value was 0.87; therefore, no additional intervention was performed.Slow flow was confirmed in the lad and right coronary artery (rca).The slow flow disappeared in the final imaging of the procedure.The details of the treatment are unknown.At a later date, reverse redistribution was confirmed in stressed myocardial scintigraphy; therefore, combination with microvascular angina was suspected.

Manufacturer Narrative

Internal file number: (b)(4).The device was not returned for evaluation.The reported patient effects of angina, ischemia, vasoconstriction (coronary artery spasm) and stenosis are listed in the xience alpine, everolimus eluting coronary stent system instructions for use, as known patient effects of coronary stenting procedures.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 effect, and the relationship to the product, if any, cannot be determined.Additionally, the reported treatments appear 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 of the device.

• 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: 8655577
• MDR Text Key: 146546630
• Report Number: 2024168-2019-04224
• 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: literature
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2017
• Device Catalogue Number: 1125275-15
• Device Lot Number: 4120441
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STENT: CYPHER (X2), 3.0X23MM XIENCE ALPINE; STENT: CYPHER (X2), 3.0X23MM XIENCE ALPINE; STENT: CYPHER (X2), 3.0X23MM XIENCE ALPINE; STENT: CYPHER (X2), 3.0X23MM XIENCE ALPINE; STENT: CYPHER (X2), 3.0X23MM XIENCE ALPINE; STENT: CYPHER (X2), 3.0X23MM XIENCE ALPINE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR