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

Catalog Number 1070300-18

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

Patient Problems Angina (1710); Stenosis (2263)

Event Date 08/14/2019

Event Type  Injury  

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 stenosis and angina are listed in the xience xpedition, everolimus eluting coronary stent system (eecss), instructions for use as known patient effects 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 manufacture, design or labeling of the device.The additional 3.25x28mm xience xpedition stent referenced is filed under a separate medwatch report number.

Event Description

It was reported that on (b)(6) 2014, the patient was hospitalized due to paroxysmal chest tightness.On (b)(6) 2014, coronary angiography showed single-vessel lesion.Two 3.25x28mm and 3.0x18mm xience xpedition stents were successfully implanted in series in the proximal and middle left anterior descending artery (lad) with 100% diffuse stenosis.The subject was discharged on (b)(6) 2014 after improvement.The patient was compliant with dual antiplatelet drug therapy (dapt) after the procedure.On (b)(6) 2019, the patient was rehospitalized due to intermittent chest tightness and chest pain.Coronary angiography performed on the same day showed that the left main to left circumflex (lm-lcx) stent was unobstructed, 80% of the lcx middle was stenosed, the distal stenosis was 50%, the lad proximal stent was restenosed 70%, the lad middle stent restenosis was 60%, and the diagonal proximal part occlusion was 100%.A 3.0x15mm non-abbott stent was implanted in the middle section of lcx.No treatment was provided for the restenosed lad stents.The patient was discharged on (b)(6) 2019 after improvement.The event may be related to the device.The patient is currently in good physical condition.There was no adverse patient sequela and no clinically significant delay.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 (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10570527
• MDR Text Key: 208356108
• Report Number: 2024168-2020-07920
• 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 Catalogue Number: 1070300-18
• Device Lot Number: 3093041
• 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
• Patient Age: 61 YR
• Patient Weight: 75