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

Catalog Number 1009528-18

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

Patient Problems Cardiac Arrest (1762); Death (1802); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); No Consequences Or Impact To Patient (2199); Pericardial Effusion (3271)

Event Date 09/11/2020

Event Type  Death  

Manufacturer Narrative

The stent remains in the patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a moderately tortuous, moderately calcified de novo right coronary artery (rca) that is 80% stenosed.The patient presented with an inferior wall st-elevation myocardial infarction and a 2.75x18mm xience v was implanted.Post implantation, patient had a myocardial rupture.An emergency pericardiocentesis was performed; however; the rupture was too large.The patient experience hypotension and went into cardiac arrest.Patient died and no autopsy was performed.No additional information was provided.

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.Subsequent to the initial report, additional information was received stating the myocardial rupture was not related to the use of the xience v product; therefore, no further investigation is required.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: patient codes 1802, 1969, 3271, 1762, 1914 removed.

Event Description

It was reported that the procedure was to treat a moderately tortuous, moderately calcified de novo right coronary artery (rca) that is 80% stenosed.The patient presented with an inferior wall st-elevation myocardial infarction and a 2.75x18mm xience v was implanted.Post implantation patient had a myocardial rupture.An emergency pericardiocentesis was performed; however; the rupture was too large.The patient experience hypotension and went into cardiac arrest.Patient died and no autopsy was performed.Subsequent to filing the initial report, additional information was received stating the xience v stent was not related to the myocardial rupture.No additional information was provided.

• Brand Name: XIENCE DRUG ELUTING CORONARY STENT
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10652292
• MDR Text Key: 210505144
• Report Number: 2024168-2020-08396
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2022
• Device Catalogue Number: 1009528-18
• Device Lot Number: 0012941
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death