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

Model Number 1804225-23

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

Patient Problems Hematoma (1884); Myocardial Infarction (1969)

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

The stent remains in 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 on (b)(6) 2021 the patient underwent a coronary intervention.The lesion was confirmed with intravascular ultrasound (ivus) and the 2.25x23 mm xience skypoint stent was implanted at 12 atmospheres in the left anterior descending (lad) coronary artery.The lesion was more than 20mm, eccentric, mild tortuosity, mild calcification, no-entrance location, no branches, no thrombosis, non chronic totally occluded (cto) lesion.A balloon was used for post dilatation per standard practice.The next day, on (b)(6) 2021, the patient was still in the hospital and they experienced a myocardial infarction in the lad.Hematoma was also found 5 mm distal to the distal part of the stent.Impaired flow of blood was noted on the main trunk.There was no remark of stent thrombosis and blood circulation did not improve.At occurrence of the event, three anti-platelets (prasugrel, aspirin, and doac) were prescribed (one for each).There was no other treatment performed.It is unknown if the hospitalization was increased due to the issues.No additional information was provided.

Event Description

It was reported that on (b)(6) 2021 the patient underwent a coronary intervention.The lesion was confirmed with intravascular ultrasound (ivus) and the 2.25x23 mm xience skypoint stent was implanted at 12 atmospheres in the left anterior descending (lad) coronary artery.The lesion was more than 20mm, eccentric, with mild tortuosity, mild calcification, in a no-entrance location, no branches, no thrombosis, non chronic totally occluded (cto).A balloon was used for post dilatation per standard practice.The next day, (b)(6) 2021, the patient was still in the hospital and they experienced a myocardial infarction in the lad.Hematoma was also found 5 mm distal to the distal part of the stent.Impaired flow of blood was noted on the main trunk.There was no remark of stent thrombosis and blood circulation did not improve.At occurrence of the event, three anti-platelet medications (prasugrel, aspirin, and doac) were prescribed (one for each).There was no other treatment performed.It is unknown if the hospitalization was increased due to the issues.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.The reported patient effects of myocardial infarction and hematoma are listed in the xience skypoint, everolimus eluting coronary stent system (eecss), electronic instructions for use (eifu) 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; however, the reported treatment 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.

• Brand Name: XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY 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: 13040113
• MDR Text Key: 287025538
• Report Number: 2024168-2021-11854
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233012
• UDI-Public: 08717648233012
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1804225-23
• Device Catalogue Number: 1804225-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Disability
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 69 KG