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

Model Number 1804300-12

Device Problem Material Deformation (2976)

Patient Problems Angina (1710); Dyspnea (1816); Pain (1994); Obstruction/Occlusion (2422)

Event Date 02/28/2023

Event Type  Injury  

Event Description

It was reported that on 1/31/2022, a 3.0x23mm xience skypoint was implanted in the left anterior descending artery.A second 3.0x12mm xience skypoint was implanted in the proximal diagonal with no issues.During the winter time the patient began to experience chest pain, shortness of breath and pain in the arm.On 2/28/2023, it was confirmed both stent's had collapsed and a new unspecified stent was implanted followed by additional angioplasty.There was no adverse patient sequela and no clinically significant delay reported.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.The additional xience skypoint device referenced is filed under separate medwatch report number.

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 reported patient effects of obstruction/ occlusion, angina, pain, and dyspnea 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 material deformation and 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.

• 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: 16612500
• MDR Text Key: 311964477
• Report Number: 2024168-2023-03024
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233227
• UDI-Public: 08717648233227
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2023

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 Expiration Date: 03/25/2023
• Device Model Number: 1804300-12
• Device Catalogue Number: 1804300-12
• Device Lot Number: 1032241
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/24/2023
• Supplement Dates Manufacturer Received: 04/07/2023
• Supplement Dates FDA Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2021
• 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): Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 127 KG