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

Catalog Number 1500350-28

Device Problems Material Separation (1562); Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 11/12/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.The device was returned for analysis.The reported packaging problem (kinked coil) was confirmed.Additionally, the proximal catheter shaft was separated and the fracture faces were kinked and jagged.The catheter shaft had several kinks and the coil dispenser was returned with 6 kinks that matched the catheter kinks.The reported damage to the device packaging (chipboard box) could not be confirmed as the box 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.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.The investigation was unable to determine a conclusive cause for the reported damages.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that during unpacking/before use of a 3.50x28mm xience sierra stent delivery system (sds), the chipboard box was damaged [scratched] and the dispenser hoop coil was noted as kinked.The sds catheter remained in the kinked dispenser.The device was not used and there was no patient involvement.There was no clinically significant delay in the procedure.No additional information was provided.Returned device analysis on 12/16/2019 noted a hypotube separation, that the account was unable to confirm.

• Brand Name: XIENCE SIERRA
• 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: 9565580
• MDR Text Key: 177985995
• Report Number: 2024168-2020-00463
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Catalogue Number: 1500350-28
• Device Lot Number: 9082741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2019
• 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