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

Model Number 1550300-15

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 09/15/2021

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 during preparation and before use, when the box was opened and the package containing the stent was pulled out of the box, the sticker on the foil wrapper was noted to be ripped.The device was no longer sterile.It looked like the package may have previously been opened.The device was not used and there was no patient involvement.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported tear, rip, hole in packaging (sterility breach) was 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 sterility breach.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Manufacturer Narrative

The reported tear, rip, hole in packaging (torn vendor seal) was confirmed.The noted damage did not affect the sterility of the device.The investigation was unable to determine a conclusive cause for the reported/noted torn vendor seal on the foil pouch.Additionally, no damages were noted to the inner pouch indicating that there was not a sterility breach as reported.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: 12578397
• MDR Text Key: 274796773
• Report Number: 2024168-2021-08918
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227257
• UDI-Public: 08717648227257
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2022
• Device Model Number: 1550300-15
• Device Catalogue Number: 1550300-15
• Device Lot Number: 012024A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2020
• 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