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

Catalog Number	1804325-18
Medical Device Problem Codes	Material Rupture (1546); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat the mid left anterior descending (lad) coronary artery with heavy calcification, mild tortuosity and 90% stenosis.Rotablation was performed and pre-dilatation with a 3.0x15 mm non-abbott balloon was performed and then the 3.25x18 mm xience skypoint stent delivery system (sds) was advanced without resistance to the lesion.The balloon ruptured during the first inflation to 10 atmospheres and failed to deploy the stent.The stent was still on the balloon so the entire sds was removed from the anatomy.More dilatation was performed with the 3.0x15 mm balloon and a 3.0x18 mm xience skypoint stent was deployed successfully.Post dilatation was performed with a 3.25x12 mm nc trek balloon to complete the procedure.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.
Additional 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 investigation was unable to determine a conclusive cause for the reported material rupture.The reported activation failure appears to be related to operational context of the procedure as the reported rupture likely caused the reported failure to deploy (activation failure).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
• 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: 18389785
• Report Number: 2024168-2023-14411
• Device Sequence Number: 4072365
• Product Code: NIQ
• UDI-Device Identifier: 08717648233326
• UDI-Public: 08717648233326
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/23/2023

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 Expiration Date: 04/03/2026
• Device Catalogue Number: 1804325-18
• Device Lot Number: 3041241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 12/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2023
• 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
• Patient Sex: Unknown