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

Model Number	1804275-12
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
Type of Reportable Event	Malfunction
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; however, factors that may contribute to material ruptures include, but are not limited to, material damage, interactions with other devices or interaction with lesion calcification and tortuosity.The product risk assessment identifies this as a foreseeable event; as such, design and manufacturing controls and mitigation's have been established for potential causes.There was no damage or leak noted to the stent delivery system (sds) during the inspection prior to use or during preparation of the device, which suggests a product quality issue did not contribute to the reported difficulties.Based on the information provided, a definitive cause for the reported material rupture cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the patient presented with an acute myocardial infarction (ami) and the procedure was to treat the left anterior descending (lad) coronary artery with moderate calcification, moderate tortuosity and 90% stenosis.Intravascular ultrasound (ivus) was performed and the 2.75x12 mm xience skypoint stent was placed.The balloon was inflated once at 5 to 6 atmospheres (atm) for 5 seconds and ruptured.The stent delivery system was removed without resistance and the stent was confirmed with angiography to be deployed.Post-dilatation was performed about 3 times with a 2.75x10mm balloon and it was confirmed with ivus that the stent was completely apposed and the procedure was completed.It was reported that the stent easily crossed and was apposed as it was short length stent.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information 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
• MDR Report Key: 12214891
• Report Number: 2024168-2021-06379
• Device Sequence Number: 3036009
• Product Code: NIQ
• UDI-Device Identifier: 08717648233142
• UDI-Public: 08717648233142
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/22/2021

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: 09/07/2023
• Device Model Number: 1804275-12
• Device Catalogue Number: 1804275-12
• Device Lot Number: 0090241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: HEARTRAIL 6F; GUIDE WIRE: SION BLUE