MAUDE Adverse Event Report: VASCUTEK LTD SEALED EPTFE; TAPERFLO

Catalog Number W40T0406S

Device Problems Occlusion Within Device (1423); Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: actual device not evaluated - the device was not returned to vascutek as it was not available for return.All remaining devices from the batch have been sold.Manufacturing review - a complete review of the manufacturing and qc records was carried out.No issues were identified photographic inspection - images provided by the complainant were reviewed by vascutek clinical department associate.Conclusion - procedure related event.Results: operational problems.Conclusion: use error caused or contributed to event.Device not returned.A review of manufacturing and qc records confirmed that the device was manufactured to specification.A review of similar events was completed for 5-year period which gave a low occurrence rate of (b)(5).This is first complaint for occlusion failure for taperflo graft.No other complaints have been received for other units of the same batch.No issues or adverse trends were noted during the preliminary investigation.As the explanted graft was not available for evaluation the images of the incident were provided.Images were reviewed by vascutek clinical department and it was determined that judging by the information provided the event is procedure related.The graft was crushed flat possibly due to puncture technique not being followed.On the image of the explanted graft puncture holes are noticeable on both sides.Puncture of both graft walls might have caused restricted/if any blood flow which would probably flatten the graft and could have contributed to the jelly like substance, most probable thrombus formation.As the event was deemed to be procedure related, no corrective actions were assigned.No further action is required.Vascutek consider this case closed.

Event Description

Terumo (b)(4) reported graft occlusion: the 10th day after implant, puncturing was performed since the condition of the patient looked good with no swelling.The patient was then discharged from the hospital and sent back to the clinic in which the patient had been hospitalized originally.The 37th day after implant, the patient was sent back to the hospital again because the graft was occluded.When the graft was explanted, the following were found: jelly-like substances surrounding the graft did not adhere to the graft.The graft was flat, and when the graft was punctured with a needle, the needle perforated the front and rear walls of the graft.A low-echoic area of seroma-like substances was observed around the entire length of the graft which was crushed flatly.When the graft was replaced with a thoratec graft, the implanted graft was easily removed without adhering to the tissue.

• Brand Name: SEALED EPTFE
• Type of Device: TAPERFLO
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: carolyn forrest ; newmains avenue; inchinnan business park; renfrewshire, PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 7361901
• MDR Text Key: 103526555
• Report Number: 9612515-2018-00002
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881009599
• UDI-Public: 05037881009599
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K092863
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/21/2018,03/22/2018

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: 01/31/2022
• Device Catalogue Number: W40T0406S
• Device Lot Number: 1590465-9805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/21/2018
• Device Age: 12 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/21/2018
• Initial Date Manufacturer Received: 02/21/2018
• Initial Date FDA Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention