MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE ALPINE OTW EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Model Number	1145350-23
Medical Device Problem Codes	Material Rupture (1546); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The other xience alpine stent system referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was performed to treat a moderately calcified lesion in the right coronary artery (rca).Two xience alpine stent systems were used.With each stent delivery system, the balloon was inflated and the stent was deployed.Each balloon lost pressure and deflated almost immediately.A balloon rupture was suspected in each device.The stent delivery systems were removed without resistance and the stents remained at the target lesion.Post dilatation was performed with each stent, as it could not be determined if the stents were fully apposed to the vessel wall.There was no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported material rupture was unable to be confirmed as the balloon inflated and held pressure.The reported delayed/difficult activation was not confirmed as the stent was implanted and not returned for evaluation.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 as no rupture was identified during return device analysis.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.Additionally, the investigation was unable to determine a conclusive cause for the reported delayed/difficult activation; however, factors that may contribute to delayed/difficult activations include, but are not limited to, damage to the device, patient anatomical morphology, patient disease state, and inflation technique.The reported treatment appears to be related to operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE ALPINE OTW EVEROLIMUS ELUTING CORONARY STENT 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: 11712009
• Report Number: 2024168-2021-03407
• Device Sequence Number: 19791503
• Product Code: NIQ
• UDI-Device Identifier: 08717648200267
• UDI-Public: 08717648200267
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2021

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 Expiration Date: 11/26/2022
• Device Model Number: 1145350-23
• Device Catalogue Number: 1145350-23
• Device Lot Number: 9111841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 05/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention