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

Catalog Number 1508250-15

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889); Packaging Problem (3007)

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

Event Date 08/03/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.

Event Description

It was reported that the dispenser coil of the 2.5x15mm xience pros stent delivery system (sds) was kinked.The sds was removed from the dispenser coil; however, it was noted that the proximal shaft was kinked.Additionally, resistance removing the protective sheath off the sds was noted.Although the device was damaged the stent was able to be deployed successfully.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

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 other incidents from this lot.It was reported the xience pros stent delivery system (sds) was used after a shaft kink was noted.It should be noted that the xience pros everolimus eluting coronary stent system instruction for use states: prior to using the xience pro everolimus eluting coronary stent system, carefully remove the system from the package and inspect for bends, kinks, and other damage.Do not use if any defects are noted.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, inadequate storage and product damage during handling by user.Additionally, the kinked shaft and difficulty to remove appear to be related to operational context of the procedure.It is likely the kink from the protective coil interacted with the proximal shaft causing the reported deformation due to compressive stress (shaft kink) and subsequent difficulty to remove from the protective sheath.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.

• 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
• MDR Report Key: 12414421
• MDR Text Key: 269555376
• Report Number: 2024168-2021-07830
• Device Sequence Number: 1
• Product Code: NIQ
• 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: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1508250-15
• Device Lot Number: 1061641
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1