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

Catalog Number 1500350-33

Device Problems Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

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

Event Date 11/13/2023

Event Type  malfunction  

Event Description

It was reported that during preparation of the xience sierra stent delivery system, after removal of the yellow protective sheath, the stent slipped off the balloon.No patient was involved.A non-abbott stent was used to complete the procedure.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

Subsequent to the previously filed report, additional information was received that resistance was felt during removal of the protective sheath.A normal amount of force was applied during removal of the sheath.No resistance was felt during removal of the sds (stent delivery system) from the dispenser coil.The sds was prepped after the sheath removal.There was no notable manipulation/handling of the stent implant at any point.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported stent dislodgement was confirmed.The reported difficulty to remove could not be replicated 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 similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty to remove (sheath/stylet) and stent dislodgement; however, factors that can contribute to difficult to remove from the sheath/stylet include, but are not limited to, kinks, bends, procedural technique, damage during manufacturing, inadvertent mishandling during unpackaging.Factors that may contribute to stent dislodgment prior to use include, but are not limited to, crimping during manufacturing, incorrect sheath sizing, negative pressure during sheath removal, forced sheath removal, mishandling during product preparation for use, or interaction with accessory devices.The product risk assessment identifies this as a foreseeable event.In this case, it is possible that inadvertent mishandling during unpackaging and/or during preparation of the device contributed to the reported difficult to remove (sheath/stylet), ultimately causing the stent to dislodge during sheath/stylet removal, as resistance was noted; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE SIERRA 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: 18256619
• MDR Text Key: 329608172
• Report Number: 2024168-2023-13382
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: AU
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1500350-33
• Device Lot Number: 3040441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2023
• 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