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

Model Number 1125300-28

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889); Material Too Soft/Flexible (4007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that during a coronary artery intervention, after deploying the xience alpine stent, the stent delivery system (sds) balloon was used to post dilate the implanted stent; however, after the second or third inflation, the balloon failed to deflate and became softened.The sds was pulled with force to the guiding catheter and the sheath, resulting in the distal shaft separating.The entire system, including the separated distal shaft, was removed as one unit.Upon removal, it was noted that the proximal shaft was distorted and smashed.There was no adverse patient effect or a clinically significant delay in procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported material separation and deformation due to compressive stress were confirmed and the reported soft material was confirmed by the stretched outer member.The reported deflation problem and difficulty to remove could not be confirmed due to the condition the device was 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 other incidents from this lot.It was reported xience alpine stent delivery system (sds) was removed using excessive force.It should be noted that the xience alpine everolimus eluting coronary stent system instruction for use states: applying excessive force to the delivery system can potentially result in loss or damage of the stent and/or delivery system components.It appears the ifu deviation contributed to the reported event.The investigation was unable to determine a conclusive cause for the reported deflation issues; however, factors that may contribute to deflation issues include, but are not limited to, manufacturing damage, contrast mixing, bent/kinked shaft while inside the anatomy affecting the deflation lumen and/or stretched outer member (om) thereby reducing the deflation lumen.It is likely the deflation issue caused the reported difficulty to remove and subsequent material separation.It is; however, unclear if the damaged shaft (deformation due to compressive stress and soft material) is related to handling and or manipulation of the device prior to the reported deflation issue or caused by the removal by force.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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
• MDR Report Key: 10112788
• MDR Text Key: 193623771
• Report Number: 2024168-2020-04689
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648199370
• UDI-Public: 08717648199370
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2022
• Device Model Number: 1125300-28
• Device Catalogue Number: 1125300-28
• Device Lot Number: 9061441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Date Manufacturer Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1