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

Catalog Number 1070350-38

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

Patient Problems Angina (1710); Dyspnea (1816); Occlusion (1984); Stenosis (2263)

Event Date 07/30/2018

Event Type  Injury  

Manufacturer Narrative

There was no reported device malfunction and the product was not returned.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, occlusion and stenosis are listed in the instruction for use everolimus eluting coronary stent systems xience xpedition, as known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effects 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.

Event Description

Patient id: (b)(6).It was reported that on (b)(6) 2014, the patient presented with chest pain.Coronary angiography was performed, showing 85% stenosis in the proximal right coronary artery (rca) and a 3.5x38mm xience xpedition stent was successfully implanted.On (b)(6) 2014, the patient was discharged.On (b)(6) 2018, the patient was re-hospitalized for chest tightness.On (b)(6) 2018, coronary angiography showed 100% occlusion in the stent in the proximal rca.Balloon dilatation was performed.On (b)(6) 2018, the patient was discharged.On (b)(6) 2019, the patient was re-hospitalized for shortness of breath, chest tightness and neck tightness.On (b)(6) 2019, coronary angiography noted 100% restenosis.Two non-abbott stents were implanted.On (b)(6) 2019, the patient was discharged, but was still experiencing some symptoms.No additional information was provided.

• Brand Name: XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10567276
• MDR Text Key: 207979512
• Report Number: 2024168-2020-07894
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2015
• Device Catalogue Number: 1070350-38
• Device Lot Number: 3091641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 75