MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION STENTS ADVANTA V12; STENT, ILIAC

Model Number 85322

Device Problem Component Missing (2306)

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

Event Date 04/07/2023

Event Type  malfunction  

Event Description

Opened a 6x38x80 v12 to use in case and box contained the ifu and no stent.Patient was prepped and ready when they opened box and discovered stent was not there.Did not affect case, opened a new box.Patient not affected and surgeon not upset.

Manufacturer Narrative

Upon completion of the investigation into this event a follow up report will be submitted.

Event Description

N/a.

Manufacturer Narrative

Investigation summary: opened a 6x38x80 v12 to use in case and box contained the ifu and no stent [or catheter delivery system].Did not affect case.Opened a new box.Upon receiving the device package back from the field, it was clear the product was not in the box.There was no delivery system or stent included.The product box had not been opened properly as the box was opened from the opposite side by peeling back the product label instead of using the perforated thumb tab that is clearly marked.This thumb tab was still intact but did have slight damage likely due to the excessive handling of the product.The thumb tab had not been previously opened.Being that the product was not in the box, the complaint has been confirmed however we cannot determine at what point the product was removed from the box or if the product left the manufacturing site without the product catheter within the package.The review of the dhr shows that this product met all quality requirements and that there had been one box damaged and a new label and box created to accommodate this one packaged device.The label affected by this was (b)(4).The product label associated with this complaint is (b)(4).The product in question had also expired as of 29 may 2023.The details indicate that the procedure was conducted on (b)(6) 2023 and was not reported until 21 apr 2023.Further correspondence and evidence that the product had been used prior to the complaint being issued has been provided.The hospital has provided that the product was used on 05 aug 2020 and a replacement arrived on 18 nov 2020.An image of one of the peel-off labels was provided from the hospital log book.Additionally, it appears that this unit (potentially without the product in the box) was returned to the warehouse by hawkes bay hospital on 04apr2021.It was placed back into stock at the warehouse and sent back out to (b)(6) hospital on (b)(6) 2021.Being that the device was claimed to be used originally on 05 aug 2020 and the box opened from the wrong location where the label holds the other end of the box closed it is a possibility that an empty box was returned to the warehouse then re-issued back to hawkes bay hospital and went unnoticed until the recent event where the product was to be used in a separate clinical case.Although there is evidence that the product was used there is also evidence that the product was returned although the box may have been empty upon returning to the warehouse and gone unnoticed because of the way it was opened and closed with the label re-adhered.In this regard the root cause is impossible to define.There is no evidence based on the review of the device history records that the product was packaged without the actual product being within the package.Based on the investigation there is no indication of any non-conformance, nor a design, labeling, or manufacturing problem.This is the only complaint associated with this production lot of finished goods.The complaint history shows that this is the only complaint in the last 15 months related to no product being in the box.There has also been no non-conformances noted for product not being within the product box going back 2 years.The trending shows that the product is within the control limits and the hazardous situation is adequately covered in the risk-based documents.Escalation determination: escalation is not required for this complaint.The complaint has been confirmed, but there is no indication of any nonconformance, nor a design, labeling, or manufacturing problem.The complaint is adequately covered in the risk management file, is operating within the approved risk profile, and no adverse trends have been detected.

• Brand Name: STENTS ADVANTA V12
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 17105224
• MDR Text Key: 317215114
• Report Number: 3011175548-2023-00141
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2023
• Device Model Number: 85322
• Device Catalogue Number: 85322
• Device Lot Number: 460669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 04/21/2023
• Initial Date FDA Received: 06/12/2023
• Supplement Dates Manufacturer Received: 07/27/2023
• Supplement Dates FDA Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1