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

Catalog Number 1070300-28

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

Patient Problems Angina (1710); Death (1802); Stenosis (2263)

Event Date 06/26/2019

Event Type  Death  

Manufacturer Narrative

Date of death is estimated.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 death, angina and stenosis is listed in the xience xpedition everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary procedures.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.However, the treatment(s) 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.

Event Description

It was reported that on (b)(6) 2014 the patient was hospitalized with a ten year history of chest pain and 12 hours of upper abdominal pain after activities.Coronary angiography was performed and showed three vessel lesions.A 3.0x28mm xience xpedition stent was implanted in a 100% stenosed lesion in the proximal right coronary artery (rca).The patient was discharged on (b)(6) 2014.During a five year follow up it was reported that the patient was re-hospitalized on (b)(6) 2019 for reoccurrence of angina and drug treatment was provided.The patient was discharged on (b)(6) 2019.On (b)(6) 2019 the patient was re-hospitalized with recurrence of angina, more serious than before.On (b)(6) 2019, coronary angiography was performed and showed the stent on the proximal rca with 80% re-stenosis.A 3.5x12 non-abbott stent was implanted successfully in the proximal rca and a 2.5x20mm unspecified stent was implanted in the proximal of the rca and pla [posterior left ventricular branch].The patient was discharged on (b)(6) 2019 after improvement.The patient continued to suffer from heart problems following and expired in (b)(6) 2019, the cause of death is unknown.The event was possibly related to the device.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: 10649196
• MDR Text Key: 210416933
• Report Number: 2024168-2020-08379
• 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: 10/08/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2016
• Device Catalogue Number: 1070300-28
• Device Lot Number: 4032441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 79 YR
• Patient Weight: 60