MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE ACUSEAL VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Catalog Number ECH060040

Device Problems Mechanical Problem (1384); Peeled/Delaminated (1454); Obstruction of Flow (2423)

Patient Problem No Information (3190)

Event Date 12/23/2019

Event Type  Injury  

Manufacturer Narrative

Patient age, date of birth, weight were requested but could not be obtained yet.The date of implantation was requested but could not be obtained yet.The date of explantation was requested but could not be obtained yet.The physicians phone number was requested but could not be obtained yet.Two screenshots of an ultrasound examination dated (b)(6) 2019, were provided to gore.We cannot perform an imaging evaluation with the pictures provided.The dicom series of the examination were requested but not provided to gore yet.

Event Description

It was reported that the patient received a gore acuseal vascular graft as an upper arm loop, which occluded and was revised by thrombectomy several times previously.Reportedly, now, (b)(6) 2019, the gore acuseal vascular graft is patent but ultrasound examination revealed some blood flow disturbances in the graft lumen and "compression", "deformation", "disturbances" in "pfvr".It was stated that the deformation is not in the region where they puncture the gore acuseal vascular graft.It was stated, that the physician suspected a dissection in the gore acuseal vascular graft, but he cannot confirm that they might have punctured the gore acuseal vascular graft in between the three layers recently.It was reported, that the patient was scheduled at the emergency program to explant the suspected part of the gore acuseal vascular graft.On unknown date the gore acuseal vascular graft was explanted.

Event Description

Reportedly, on (b)(6) 2019, the gore acuseal vascular graft is patent but ultrasound examination revealed some blood flow disturbances in the graft lumen and "compression", "deformation", "disturbances" in "pfvr".It was stated that the deformation is not in the region where they puncture the gore acuseal vascular graft.It was stated, that the physician suspected a dissection in the gore acuseal vascular graft, but he cannot confirm that they might have punctured the gore acuseal vascular graft in between the three layers recently.It was reported, that the patient was scheduled at the emergency program to explant the suspected part of the gore acuseal vascular graft on (b)(6) 2019.Reportedly, percutaneous transluminal angioplasty (pta) was performed on other parts of the implanted graft.It was reported, that after the explantation the physician visually inspected the explant and took pictures.It was stated, that the explant showed a "little bit weird coloration¿ and that ¿the inner layer became loose".After this, the explant was discarded at the facility.Reportedly, the patient outcome was good.

Manufacturer Narrative

H6-code 3331: the investigation involved the analysis of relevant production records in view of supporting the identification of possible causes for the adverse event.H6-code 4112: additional images of the explanted device and screenshots of x-rays have been provided by the physician.H6-code 3221: a review of the manufacturing records verified that the lot involved in this event met all pre-release specifications.The images of the explanted device are not of sufficient quality to perform an engineering evaluation.No imaging evaluation could be performed on the provided x-ray screenshots.

Manufacturer Narrative

Adverse event or product problem: corrected (previously "product problem"; present report "adverse event").Outcomes attributed to adverse event: updated.Corrected (previously "malfunction"; present report "serious injury").

Manufacturer Narrative

H6-code 213: updated results code, because an incorrect code (3221) was provided previously by human error: a review of the manufacturing records verified that the lot involved in this event met all pre-release specifications.The images of the explanted device are not of sufficient quality to perform an engineering evaluation.No imaging evaluation could be performed on the provided x-ray screenshots.

Manufacturer Narrative

H6: the device code was updated to match the mapped imdrf code.

• Brand Name: GORE ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9605774
• MDR Text Key: 197663807
• Report Number: 2017233-2020-00047
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2022
• Device Catalogue Number: ECH060040
• Device Lot Number: 6204461PP010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 39 YR
• Patient Weight: 66