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

Catalog Number 1120300-12

Device Problems Material Separation (1562); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2021

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a heavily calcified and heavily tortuous vessel in an unspecified artery.The 3.0x12mm xience alpine stent delivery system (sds) stent dislocated from the balloon due to the tortuosity of the vessel.Another xience stent was used to complete the procedure.There was no reported adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.

Event Description

It was reported that the procedure was to treat a heavily calcified and heavily tortuous vessel in an unspecified artery.The 3.0x12mm xience alpine stent dislocated from the balloon due to the tortuosity of the vessel.Another xience stent was used to complete the procedure.There was no reported adverse patient effect and there was no clinically significant delay in the procedure.Returned analysis identified the inner and outer member (entire distal shaft) were separated 2.5mm distal to the guide wire exit notch and were not returned.It was confirmed that the account was aware of the separation.There is the possibility that the separated portion remains in the patient anatomy.No additional information was provided.

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.H1 - type of reportable event updated from "malfunction" to "serious injury".H6 - health effect - clinical code 4582 was removed and code 2687 was added.H6 - health effect - impact code 2199 removed.

Manufacturer Narrative

A visual inspection was performed on the returned device.The reported device dislodged or dislocated and failure to advance were not tested due to the component not being returned.The reported material separation was confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported failure to advance and device dislodged or dislocated are related to the operational context of the procedure.Additionally, the investigation was unable to determine a conclusive cause for the reported material separation.In this case, it is likely that the sds interacted with the heavily tortuous and heavily calcified anatomy, contributing to the noted twisted skive/wire/bayonet and ultimately resulting in the reported failure to advance and subsequent device dislodged or dislocated.Factors that could contribute to material separation include, but not limited to, patient disease state, anatomical morphology, user technique, and interaction with accessory devices.In this case, it is possible that the sds interacted with the challenging anatomy during retraction, contributing to the reported material separation; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.B1 - adverse event/product problem "adverse event" was removed.B2 - outcomes attributed to ae "other serious" was removed and replaced with "na".H1 - type of reportable event updated from "serious injury" to "malfunction".H6 - health effect - clinical code 2687 was removed and 4582 added.H6 - health effect - impact code 2199 added.

Event Description

It was reported that the procedure was to treat a heavily calcified and heavily tortuous vessel in an unspecified artery.The 3.0x12mm xience alpine stent dislocated from the balloon due to the tortuosity of the vessel.Another xience stent was used to complete the procedure.There was no reported adverse patient effect and there was no clinically significant delay in the procedure.Returned analysis identified the inner and outer member (entire distal shaft) were separated 2.5mm distal to the guide wire exit notch and were not returned.Subsequent to filing the prior reports the following information was received: it was confirmed that the account was aware of the distal shaft separation and confirmed that no part of the device remains in the patient's anatomy.No additional information was provided.

• Brand Name: XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: 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: 13043846
• MDR Text Key: 285634725
• Report Number: 2024168-2021-11873
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2022
• Device Catalogue Number: 1120300-12
• Device Lot Number: 9081441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other