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

Model Number	1804300-18
Medical Device Problem Codes	Difficult to Remove (1528); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the electronic lot history record and lot level similar incident review for this product was not performed because the lot number was not reported and the product was not returned for analysis.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The hi-torque bmw universal guide wire referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a calcified and mildly tortuous left anterior descending artery (lad).A 3.0x18 xience skypoint stent delivery system (sds) was advanced to the lesion over a balance middleweight (bmw) universal guide wire (gw).The stent was deployed successfully in a bent section of the lad.There was resistance during retraction of the gw and the gw was trapped under the stent struts.The gw was finally removed (simply withdrawn), and the gw was noted extremely elongated and deformed but still intact.The stent was explanted and tangled up.A new whisper guide wire and an nc trek were used to successfully complete the procedure and another same size xience skypoint was implanted to treat the target lesion.There were no reported adverse patient effects and there was no reported clinically significant delay.No additional information regarding this issue was provided.

• Brand Name: XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Common Device Name: 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: 15928862
• Report Number: 2024168-2022-12308
• Device Sequence Number: 19929574
• Product Code: NIQ
• UDI-Device Identifier: 08717648233241
• UDI-Public: 08717648233241
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/06/2022

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
• Operator of Device: Health Professional
• Device Model Number: 1804300-18
• Device Catalogue Number: 1804300-18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BMW UNIVERSAL GUIDE WIRE
• Patient Sex: Unknown