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

Catalog Number 1508350-38

Device Problems Material Separation (1562); Deformation Due to Compressive Stress (2889); Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/12/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis.The reported kinked dispenser coil, kinked shaft and material separation were confirmed.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.The investigation was unable to determine a conclusive cause for the reported packaging problem (kinked coil); however, factors that could contribute to packaging problems (kinked coil) include; but are not limited to, manufacturing damage, damaged during shipping, and product damage during handling by user.It is likely the kinked dispenser coil caused the reported shaft kink.Continued handling and/or manipulation of the kink device during removal from the kinked dispenser coil likely caused the reported material separation.There is no indication of a product quality issue with respect to manufacture, design or labeling.The xience pros is currently not commercially available in the us; however, it is similar to a device sold in the us.

Event Description

It was reported that a 3.5x38mm xience pro s drug eluting stent (des) was removed from the package when the hoop tray was noted to be kinked.The device was also kinked, and when removed from the hoop tray, the des separated into pieces without manipulation.There was no patient involvement and no clinically significant delay in the procedure.

• Brand Name: XIENCE PROS 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: 12557782
• MDR Text Key: 274235273
• Report Number: 2024168-2021-08778
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2024
• Device Catalogue Number: 1508350-38
• Device Lot Number: 1022441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1