MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ADVANTA VXT W/GDS VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number	22059
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
Report received stated that during surgery prep it was found that the product inside the package did not match the product description.The product should have been a 6mm vxt helix graft and the product inside the package was a graft without helix.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
It was reported that a 6mm non-helix (nh) graft was found inside a unit packaged as part number (pn) 22059 advanta vxt, 6mm x 40cm, 1 graft deployment system (gds), full helix (fh), straight standard wall (str-sw).It was reported that the internal and external boxes were labeled as pn 22059.Customer returned affected components including: shelf box, inner tray, a gds graft end and a graft.The outer tray was not returned; this contains the internal label.Atrium complaints department and grafts manufacturing engineering examined the returned components.The evaluation determined that the shelf box packaging was for pn 22059/ln 458755, graft was pad printed as 6mm (diameter), the graft portion measured at 44.5cm (length), gds end was from a 6mm (diameter) graft and graft was non-helix.There was no indication that a helix was previously attached and subsequently removed from the graft.It could not be confirmed if the gds was original to the returned graft as it was separated.Additionally, initial length cannot be confirmed, as it is possible the graft was cut to a shorter length.A review of the inventory showed that only one other device was left in inventory of the affected lot number (ln) 458755 was available in the warehouse inventory.The unit was returned to atrium for investigational purposes.The returned device from inventory was opened and identified that the contents of the package matched the labeling, as it was a 6mm x 40cm, 1 gds, fh, str-sw.No other units are available for review and no other complaints have been received for this product lot.The build quantity for this lot of grafts was 30 pieces.The confirmed physical attributes of the returned graft (nh, 6mm diameter and 44.5cm length) indicate that the affected unit is not from either of the two other lots in the seal session.This is because pn 22064 is 8mm in diameter and the dhr for pn 21007, ln 458941 shows all units (25) were cut to lengths at or below 35cm.Product was labeled on (b)(6) 2020.Serialized labels are placed on the shelf box (external labels), outer tray (internal label), implant tracking card and left on a sheet that is put into the ifu to be used as tracking labels.The ifu, implant card and tracking labels are placed into the shelf box.Dhr for pn 22059, ln 458755, indicates that product type and serial numbers were verified to be correct.Qc inspected the packaged product on (b)(6) 2020.Procedurally only one packaged unit is unpackaged at a time for the inspection and the unit must be repackaged before inspection of another unit can start.All thirty (30) units were inspected for particulate in the tray and for other criteria which includes that the packaged unit contains appropriate contents per the finished good specification (fgs).No units were rejected during the qc inspection.Manufacturing applies a tamper evident seal.Shelf boxes are not opened during this process.Once a tamper seal is applied shelf box is considered closed as other end was previously sealed by application of the shelf box label over the opening.No anomalies attributing to this event were noted within the dhr review for pn 22059, ln 458755.A ship history was conducted in regards to all grafts sent to the site of the complaint (the catholic university of korea, incheon st.Mary¿s hospital) and based on the ship history there have been no 6mm non-helix grafts purchased from this institution.In summary, the device history records review investigation could not find an instance or an opportunity for a non- helix 6mm to have been packaged in with this finished goods production lot advanta vxt, 6mm x 40cm,gds, fh, st (str-sw).The investigation thus far has confirmed the presence of a 6mm non-helix graft within the returned shelf box label for a 6mm x 40cm, 1 gds, fh, str-sw; however, the outer tray that has another label identifier was not returned.

• Brand Name: ADVANTA VXT W/GDS VASCULAR GRAFT
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• MDR Report Key: 10992000
• Report Number: 3011175548-2020-01430
• Device Sequence Number: 3823877
• Product Code: DSY
• UDI-Device Identifier: 00650862220599
• UDI-Public: 00650862220599
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K992960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/08/2023
• Device Model Number: 22059
• Device Catalogue Number: 22059
• Device Lot Number: 458755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 12/11/2020; 06/03/2021
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 12/26/2020; 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1