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

Catalog Number 1500400-23

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/12/2023

Event Type  Death  

Event Description

It was reported that on (b)(6) 2023, the patient presented with intermittent chest pain and a 4.0x23mm xience sierra stent delivery system (sds) was implanted in left anterior descending artery (lad).The patient was noted to be asymptomatic and discharged two days later.On (b)(6) 2023, the patient suffered a cardiac arrest, cpr was performed by the paramedics and intermittent restoration of circulation and blood pressure was obtained.However, during transit to the hospital the patient expired.Autopsy revealed a large recent myocardial infraction in the anterior wall of the left ventricle and adjacent interventricular septum.It was noted that the xience stent was patient; however, there was significant atherosclerotic stenosis of the lad distal to the stent.In a small intramyocardial artery, a small non-metallic stent matrix material (possibly the tip of a delivery catheter) was found and some macrophages were surrounding it.Cause of death was noted to be due to complication of recent massive myocardial infarction.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported material separation.Factors that may contribute to material separation include, but are not limited to, interaction with challenging anatomy, interaction with accessory devices, manipulation against resistance, or excessive force applied to device.The separated portion of the stent delivery system was discovered in the patient¿s anatomy during the autopsy.The cause of death was attributed to complications of recent massive myocardial infarction (mi).The reported patient effect of death is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design, or labeling.A medical review was performed.The reviewer stated ¿the most likely cause of death is the large anterior wall mi in the lad and the relationship of the non-metallic stent material within the intramyocardial arteries may have contributed to atherosclerotic plaque formation proximal to the artery that could have occluded the vessel and cascaded to thrombosis which eventually led to the myocardial infarction.As the device was discarded, the relationship of the nonmetallic material to the xience stent delivery system cannot be fully established.¿ b2, h1: death added.

Event Description

Based on the investigation, the most likely cause of death is the large anterior wall myocardial infarction in the lad and the relationship of the non-metallic stent material within the intramyocardial arteries may have contributed to atherosclerotic plaque formation proximal to the artery that could have occluded the vessel and cascaded to thrombosis which eventually led to the myocardial infarction.As the device was discarded, the relationship of the nonmetallic material to the xience stent delivery system cannot be fully established; however, this will conservatively be filed as a death.No additional information was provided.

• Brand Name: XIENCE SIERRA 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: 17319106
• MDR Text Key: 319019694
• Report Number: 2024168-2023-07487
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: AS
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1500400-23
• Device Lot Number: 1063041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Death
• Patient Age: 37 YR
• Patient Sex: Male