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

Model Number 1804400-18

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 06/16/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2021, the mid left anterior descending (lad) artery was pre-dilatated with a semi-complaint balloon a 3.5x48mm xience xpedition stent was implanted with no issues at 6 atmospheres.During the 12 month follow up heavy stenosis was noted in the proximal lad and 1st diagonal artery, and on (b)(6) 2023 4.0x18mm xience skypoint stent was implanted in proximal lad.First diagonal was planned to be treated on another date.On (b)(6) 2023, restenosis was confirmed only at the proximal lad where the 4.0x18mm xience skypoint was implanted.A drug coated balloon was used to treat the restenosis and treatment of the 1st diagonal was terminated as an unspecified guide wire failed to cross the lesion.There was no adverse patient sequela and no clinically significant delay.No additional information was reported.

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.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined; however, the reported treatments appear to be related to the operational context of the procedure.The reported patient effect of thrombosis is listed in the xience skypoint, everolimus eluting coronary stent system (eecss), electronic 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.

• 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: 17317450
• MDR Text Key: 319009833
• Report Number: 2024168-2023-07472
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233487
• UDI-Public: 08717648233487
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/08/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1804400-18
• Device Catalogue Number: 1804400-18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 08/02/2023
• Supplement Dates FDA Received: 08/08/2023
• 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): Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 61 KG