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

Catalog Number 1800350-38

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

Patient Problems Angina (1710); Obstruction/Occlusion (2422); Prolapse (2475)

Event Date 01/31/2024

Event Type  Injury  

Manufacturer Narrative

D4: the udi is unknown as the part/lot number was not provided.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 a xience skpoint stent was implanted.Ten minutes after the case, stenosis occurred.Upon re-accessing the target site, plaque was noted to be protruding between cells.Additional intervention was performed as treatment.There was no adverse patient sequela.No additional information was provided.

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.The reported patient effect of occlusion, prolapse and angina are listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as a 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 subsequent 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; therefore, no product-related corrective action will be implemented in this case.

Event Description

Subsequent to the initially filed reports, it was reported the patient presented with st elevation myocardial infarction (stemi).The procedure was performed to treat a lesion in the left anterior descending (lad) coronary artery with no calcification, mild tortuosity and 60% stenosis.Post stent implant, the patient experienced chest pain and intravascular ultrasound (ivus) confirmed plaque was protruding between cells.An unspecified drug coated balloon dilatation catheter was used to treat the plaque protrusion.No additional information was provided.

• 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: 18842012
• MDR Text Key: 336956443
• Report Number: 2024168-2024-02769
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648230257
• UDI-Public: (01)08717648230257(17)260611(10)3062241
• Combination Product (y/n): Y
• Reporter Country Code: SP
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1800350-38
• Device Lot Number: 3062241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/12/2023
• 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