MAUDE Adverse Event Report: THORATEC CORPORATION VECTRA VASCULAR ACCESS GRAFT (D: 5MM, L: 40CM); PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number 1010880

Device Problems Mechanical Problem (1384); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2020

Event Type  malfunction  

Manufacturer Narrative

This is an event that occurred in (b)(6) general hospital.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that during the implant, the product under the skin, the outer layer was peeled off when the product was pulled slightly.When the loose suture at the anastomotic part was pulled, the anastomotic part of the product was torn.The graft was exchanged, and the treatment was completed.

Event Description

Additional information stated that during the procedure, after anastomosing the product into a vein, the product was subcutaneously transplanted to the skin incision in the loop, but because the vein side was bent, an attempt was made to adjust the position with a subcutaneous conduction tunneller (other manufacturer's device) but it was impossible.After this, the subcutaneous conduction tunneller was removed and the product was pulled from the loop portion side for position adjustment, the product was then damaged.

Manufacturer Narrative

Section b5: additional information.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event was confirmed during the evaluation of the returned graft.The graft was returned cut into two segments, measuring 33.5cm and 6.5cm.Visual inspection found that the reinforcing monofilament was unraveling from one end of each segment.The outer layer of the grafts appeared torn and wrinkled adjacent to the unraveled monofilament.It appeared that the monofilament had been pulled out from the graft.The relevant sections of the device history records for vascular access graft, lot number 6964314, were reviewed and showed no deviations from manufacturing or quality assurance specifications.The manufacturing history for this part (including other lots) was also reviewed, and revealed no issues related to graft damage and/or monofilament unraveling.A specific cause for the observed damage could not be conclusively determined.The vectra vascular access graft instructions for use (ifu) states that the graft should not be pulled (axially elongated) or stretched during handling at implantation.The graft should be trimmed long enough to prevent stress on the anastomosis and allow for a full range of body motion when implanted.Excessive elongation or stretching of the graft will damage the microporous layers of the graft.When positioning and trimming the graft, avoid those areas of less dense reinforcement, especially near the anastomotic end.The non-reinforced segment must be trimmed to allow for proper sizing of the graft.The ifu states that, because the graft can be damaged if pulled excessively, it is necessary to use a vectra vag sheath tunneler with this graft.The vectra sheath tunneler should be used to minimize subcutaneous trauma and the force required to position the graft during implant.Tunneling permits graft placement without pulling - which can produce excessive forces that result in damage to the graft microporous layers.Do not attempt to reposition the graft after sheath removal.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: VECTRA VASCULAR ACCESS GRAFT (D: 5MM, L: 40CM)
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10627770
• MDR Text Key: 211467504
• Report Number: 2916596-2020-04734
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2020

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: 05/28/2024
• Device Model Number: 1010880
• Device Lot Number: 6964314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 10/05/2020
• Supplement Dates Manufacturer Received: 10/23/2020; 11/20/2020
• Supplement Dates FDA Received: 10/26/2020; 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention