MAUDE Adverse Event Report: ABBOTT VASCULAR GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM; CORONARY STENT DELIVERY SYSTEM

Model Number 1012582-26

Device Problems Off-Label Use (1494); Stretched (1601); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Device Dislodged or Dislocated (2923); Material Deformation (2976); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)

Patient Problem Perforation of Vessels (2135)

Event Date 08/30/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).A visual, functional, and dimensional inspection was performed on the returned device.The reported torn outer member, material deformation (stent damage), stent dislodgement, stretched shaft (outer member), bent shaft (outer member) and deformation due to compressive stress were confirmed.The reported failure to advance could not be tested as it was based on operational circumstances.Additionally, a leak was noted.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents.It was reported that the graftmaster rx covered stent delivery system was being used to treat an aneurysm.It should be noted that the graftmaster rapid exchange (rx) coronary stent graft system, domestic, instructions for use (ifu) states: the graftmaster rx is indicated for use in the treatment of free perforations, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts greater than or equal to 2.75 mm in diameter.In this case, it is unknown if the ifu deviation directly caused or contributed to the reported event.In addition, it was reported that during advancement, use of force was applied.It should be noted that the ifu states: if resistance is encountered, do not force passage.Resistance may indicate damage to the device or movement of the stent graft on the balloon.It is unknown if the ifu deviation contributed to the reported event.The reported patient effect of perforation, as listed in the ifu, is a known patient effect that may be associated with use of a coronary stent in native coronary arteries.In this case, it is likely the device interacted with the previously implanted stent during advancement resulting in the reported failure to advance and deformation due to compressive stress.Further manipulation of the device during retraction likely contributed to the reported material deformation (stretched and bent stent struts on the proximal end of the stent), causing the stent to move distally, resulting the reported stent movement/dislodgement, in addition to the reported stretched and bent outer member and noted stretched inner member and wrinkled outer member, ultimately causing the reported tear in the outer member and noted tear in the inner member, resulting in the noted leak.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.The other graftmaster stent system referenced is filed under a separate medwatch report number.

Event Description

It was reported that the patient presented with a non-st elevation myocardial infarction and cardiac arrest.Mild extravasation was noted around an old covered stent, which was implanted on (b)(6) 2017, going into a pre-existing proximal aneurysm in the saphenous vein graft to obtuse marginal.A 4.0x26mm graftmaster stent system was advanced for treatment of the aneurysm, but after a lot of manipulating, failed to reach the aneurysm.Upon removal of the device, it was noted that the stent was dislocated and the delivery system was torn and stretched.Next the 4.5x26mm graftmaster stent system was advanced for treatment of the aneurysm, but failed to reach the aneurysm.There was evidence of worsening extravasation into the aneurysm.Transient no flow was noted.Balloon angioplasty was performed for one minute and improved the transient no flow.A non-abbott stent was implanted, successfully resolving the issues.No additional information was provided.

• Brand Name: GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
• Type of Device: CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12523748
• MDR Text Key: 273113549
• Report Number: 2024168-2021-08534
• Device Sequence Number: 1
• Product Code: MAF
• UDI-Device Identifier: 08717648176463
• UDI-Public: 08717648176463
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H000001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 1012582-26
• Device Catalogue Number: 1012582-26
• Device Lot Number: 1043041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2021
• 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
• Treatment: PREVIOUSLY IMPLANTED COVERED STENT
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 95