MAUDE Adverse Event Report: ABBOTT VASCULAR INC. XIENCE SKYPOINT¿; CORONARY DRUG-ELUTING STENT

Model Number	1804225-28
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat a heavily calcified and tortuous lesion in the left anterior descending coronary artery.Pre-dilation was performed with a 2.5x20 nc trek neo balloon dilatation catheter (bdc).The 2.75x23mm xience skypoint stent delivery system (sds) was advanced yet failed to cross the lesion due to patient anatomy.The 2.25 x28mm xience skypoint sds was advanced and again failed to cross due to patient anatomy.Upon withdrawal, resistance was felt with the anatomy and the stent dislodged.The stent became embedded in a heavily diseased area of the proximal left anterior descending coronary artery extending into the left main.Unsuccessful attempts were made to retrieve the stent with a snare.An unspecified abbott balloon was used to complete the procedure and the patient was transferred in stable condition to another facility for stent retrieval.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional device referenced in the description of incident is filed under a separate report number.
Additional Manufacturer Narrative
The device was not returned for evaluation.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database did not indicate a lot specific quality issue.A conclusive cause for the reported difficulties could not be determined; however, the subsequent unexpected medical intervention and foreign body in patient appear to be related to the operational context of the procedure.Factors that could contribute to failure to advance include, but are not limited to, patient anatomical morphology, patient disease state, pre-dilatation strategy, device placement technique, interaction with previously placed stents or accessory devices.Stent dislodgement may be attributed to several factors including, but not limited to, improper or inadequate crimping at the time of manufacture, incorrect sheath sizing, positive pressure during preparation, forced sheath removal, handling of the stent during preparation, interaction with the anatomy, or interaction with accessory devices.Factors that can contribute to difficult to remove include, but are not limited to, anatomical conditions, guiding catheter lumen obstructions, kinks, bends, procedural technique, insufficient support, or interactions with other devices.In this case, it is possible the device may have interacted with the heavily calcified, heavily tortuous lesion during advancement, causing the reported failure to advance.Further interaction with the challenging anatomy during retraction of the device, as resistance was reported, may have contributed to the reported difficult to remove, ultimately causing the reported stent dislodgement; however, without the device to examine, this cannot be confirmed.The stent became embedded in a heavily diseased area of the proximal left anterior descending coronary artery extending into the left main.Unsuccessful attempts were made to retrieve the stent with a snare.An unspecified abbott balloon was used to complete the procedure and the patient was transferred in stable condition to another facility for stent retrieval.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.

• Brand Name: XIENCE SKYPOINT¿
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 19712687
• Report Number: 2024168-2024-08118
• Device Sequence Number: 12906192
• Product Code: NIQ
• UDI-Device Identifier: 08717648233029
• UDI-Public: (01)08717648233029(17)270122(10)4013141
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2024

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
• Operator of Device: Health Professional
• Device Model Number: 1804225-28
• Device Catalogue Number: 1804225-28
• Device Lot Number: 4013141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White