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

Catalog Number 1500225-15

Device Problems Device Markings/Labelling Problem (2911); Packaging Problem (3007)

Patient Problem Insufficient Information (4580)

Event Date 02/04/2021

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that when opening the box of a 2.25 x 15 mm xience sierra stent delivery system, it was noted that the inner pouch had a size label of 2.75 x18mm and a different lot number.The xience sierra was not used and there was no patient involvement.The account reported a dissatisfaction with the lack of an opening indicator on the box to identify if the box had previously been opened.It was suspected that the box had been opened during a previous procedure and the incorrect device returned to the box; however this could not be confirmed.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported labeling problem and packaging problem 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 similar incidents from this lot.The investigation determined the reported event of product pouch label and product box mix-up most likely occurred at the receiving facility outside abbott control.It should be noted that both the xience sierra 2.25x15 mm lot identified on the box and the xience sierra 2.75x18 mm lot identified on the pouch label were shipped to the account.The lots were manufactured approximately six months apart with no relabeling eliminating the possibility the mix-up occurred during manufacturing.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• 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
• MDR Report Key: 11368523
• MDR Text Key: 240404575
• Report Number: 2024168-2021-01390
• 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: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2023
• Device Catalogue Number: 1500225-15
• Device Lot Number: 0012341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1