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

Model Number 1804225-33

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event - estimated, treatment / therapy start date - estimated.The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported the 2.25x33mm xience skypoint stent delivery system was used in a procedure and separated.There was no reported adverse patient effect and no reported clinically significant delay in the procedure.No additional information was provided.

Event Description

Subsequent to the initial medwatch report, it was noted that the following occurred sometime during this reported procedure: it was reported that the procedure was to treat a lesion in the left anterior descending (lad) artery with heavy calcification.Pre-dilatation was performed with a non-abbott balloon.Then a 2.25 x 33mm xience skypoint stent delivery system (sds) was attempted to be advanced to the target lesion; however the stent failed to cross due to anatomical challenges.Therefore, the sds was removed and resistance was noted during removal due to anatomical challenges.A flared stent strut was observed.There was no adverse patient effect and no clinically significant delay in the procedure.A second dilatation was performed with a non-abbott balloon followed by deployment of another xience skypoint stent to complete the procedure.This was filed under patient identifier cn-(b)(6).No additional information was provided.

Manufacturer Narrative

A visual and dimensional inspection was performed on the returned device.The reported material separation was confirmed.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 investigation was unable to determine a conclusive cause for the reported material separation.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: 14197866
• MDR Text Key: 290062776
• Report Number: 2024168-2022-04481
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233036
• UDI-Public: 08717648233036
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2024
• Device Model Number: 1804225-33
• Device Catalogue Number: 1804225-33
• Device Lot Number: 1011241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2022
• Initial Date FDA Received: 04/25/2022
• Supplement Dates Manufacturer Received: 04/26/2022
• Supplement Dates FDA Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2021
• 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