MAUDE Adverse Event Report: AV-TEMECULA-CT GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

Catalog Number 1012817-19

Device Problems Deflation Problem (1149); Positioning Failure (1158); Inflation Problem (1310); Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

Patient Problems Cardiac Arrest (1762); Death (1802); Foreign Body In Patient (2687)

Event Date 04/27/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: five days after the procedure, the patient was symptomatic with cardiac arrest, cardio pulmonary resuscitation (cpr) was performed and the patient expired on (b)(6) 2016.No additional information was provided.Concomitant medical products: guide wire: balance middle weight, u2, gaia 1st, runthrough.Guide catheter: 2.5x15mm ikazuki.(b)(4).A visual, dimensional and functional inspection was performed on the returned device.The reported inflation issue, stent dislodgement, shaft leak and torn material were confirmed.The reported deflation issue and failure to deploy could not be tested due to the condition of the returned device.A review of the lot history record identified no manufacturing nonconformities.Additionally, a review of the complaint history identified no other incidents.The reported patient effect of death as listed in the graftmaster coronary stent graft system instructions for use (ifu) is a known patient effect that may be associated with use of a coronary stent in native coronary arteries.It should be noted that the graftmaster coronary stent graft system ifu states: the graftmaster rx is a balloon-expandable pre-mounted coronary stent graft for intraluminal chronic placement in coronary arteries or aorto-coronary bypass grafts for the treatment of coronary artery aneurysm, coronary bypass-vein graft aneurysm, acute coronary artery perforation and acute coronary artery rupture.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation determined the reported difficulties and subsequent treatments appear to be related to circumstances of the procedure.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.

Event Description

It was reported that the procedure was to treat a dissection in the distal left anterior descending (lad) artery.A 2.8x19mm graftmaster rx stent system was advanced without resistance toward the dissection, the stent system was inflated to 15 atmospheres (atm) and the balloon did not fully inflate.Thus the stent was not fully expanded.An attempt was made to inflate the balloon to 16 atm and the balloon still appeared partially inflated.An attempt was made to deflate the balloon by applying negative pressure and the balloon failed to deflate.The stent system was withdrawn partially deflated and the stent dislodged and remained in the proximal lad.Reportedly there was no resistance during withdrawal.Upon removal of the delivery system a leak was noted near the guide wire notch.Failed attempts were made to retrieve the stent using an unspecified snare device and the double wire twist technique.While using angiography, the graftmaster stent was noted to be partially deployed to approximately 1.8mm; thus making stent retrieval from the patient anatomy more difficult.The stent remained free floating in the proximal lad and prevented other devices from reaching the dissection in the distal lad.The physician felt that removing the graftmaster stent via surgery was not a safe option due to the stent location in the proximal lad.The patient was sent to surgery to treat the distal lad dissection and coronary artery bypass grafting (cabg) was performed.It was suspected that the delivery system leak contributed to insufficient inflation and insufficient deflation.There was a clinically significant delay in the procedure.

• Brand Name: GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
• Type of Device: CORONARY STENT GRAFT
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5670207
• MDR Text Key: 45622265
• Report Number: 2024168-2016-03299
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: H000001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 1012817-19
• Device Lot Number: 5113041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2016
• Initial Date FDA Received: 05/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• 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): Death