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

Device Problems Kinked (1339); Failure to Advance (2524)

Patient Problems Hypoxia (1918); Thrombosis (2100)

Event Date 01/01/1998

Event Type  Injury  

Manufacturer Narrative

Product surveillance coordinator received a delivery failure report for the email which was sent to the authors email address.Product surveillance coordinator searched for contact details for the second and third author of this article.Research did not provide any results.As no information related to this complaint has been or will be provided by the author this event will be closed with the information provided.The device remains implanted, so no engineering evaluation could be performed.

Event Description

In the literature article "transcatheter recanalization and subsequent stent implantation for the treatment of early postoperative thrombosis of modified blalock-taussig shunts in two children," published by m.Peuster et al.In the journal of catheterization and cardiovascular diagnosis from 1998, an occlusion of two gore-tex pediatric vascular grafts were reported.The article stated that two babies with duct-dependent cyanotic congenital heart disease were palliated with modified blalock-taussig shunts.One patient was diagnosed to have tetralogy of fallot, and the other patient, tricuspid atresia type ia.Early postoperative arterial oxygen saturations dropped significantly due to shunt thrombosis.Both patients were successfully treated with angioplasty and stent implantation.Patient two, a (b)(6) baby weighing (b)(6), was diagnosed to have tetralogy of fallot with hypoplastic pulmonary arteries.Although balloon dilatation of the right ventricular outflow tract had been performed at age (b)(6), hypoxemic spells recurred after two weeks.Therefore, a blalock-taussig shunt where a gore-tex pediatric vascular graft was used, was created from the right subclavian artery to the right pulmonary artery.After the shunt was created, arterial oxygen saturations increased to 85% but dropped to 45% two days postoperatively.There was no audible shunt murmur on the right sternal border.Duplex sonography established the diagnosis of thrombotic shunt occlusion.Heparin was administered, and the partial thromboplastin time increased to 80 seconds.Clotting assays revealed no abnormalities.To confirm the diagnosis, the patient was taken to the cardiac catheterization laboratory.Using a percutaneous right femoral arterial approach, a 4f cobra catheter was advanced into the right subclavian artery.Angiography demonstrated complete thrombotic occlusion of the blalock-taussig shunt, which was suspected to be due to a kinking of the gore-tex vascular graft.The soft tip of a 0.035 guidewire was advanced through the thrombosed gore-tex vascular graft and placed into the main pulmonary artery.Thereafter, the cobra catheter could be advanced through the shunt and the 0.035 guidewire was subsequently exchanged for a 0.018 guidewire.The cobra catheter was exchanged over the wire for a ptca dilatation catheter and positioned in the occluded gore-tex vascular graft.Three balloon dilatations with inflation were performed.Repeat angiography demonstrated only a partial recanalization of the gore-tex vascular graft.Therefore, it was decided to implant a stent.A crimp-loaded palmaz-schatz-stent was inserted but could not be advanced beyond the angulated right innominate artery.Therefore, the catheter was exchanged for a crimp-loaded gianturco-roubin flex-stent.The catheter was advanced into the gore-tex vascular graft without major problems.The balloon was carefully inflated and the stent was deployed.Postinterventional angiography demonstrated a completely patent blalock-taussig shunt, as did angiography four month later.Arterial oxygen saturation ranged between 82-86%.Doppler sonography of the right femoral artery showed a patent vessel.Surgical repair of the tetralogy of fallot was performed at age (b)(6).

Manufacturer Narrative

On april 18, 2016, the following was completed by w.L.Gore & associates: date of event: (b)(6) 1998.

• Brand Name: GORE-TEX® VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: barbara ulrich ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5522219
• MDR Text Key: 41021599
• Report Number: 2017233-2016-00276
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K802095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 YR
• Patient Weight: 2