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

Catalog Number 1012817-16

Device Problems Off-Label Use (1494); Stretched (1601); Failure to Advance (2524)

Patient Problem Stenosis (2263)

Event Date 02/17/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual and dimensional inspection was performed on the returned device and noted a stretched guide wire exit notch.The reported failure to advance could not be tested as it was based on operational circumstances.It was reported that the procedure was to treat an aneurysm at the distal right coronary artery.It should be noted that the graftmaster rapid exchange (rx), coronary stent graft system, electronic instructions for use (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.The ifu deviation does not appear to have contributed to the reported event.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.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.In this case, it is likely the device interacted with the moderately calcified, heavily tortuous anatomy during advancement resulting in the reported failure to advance.Further manipulation of the sds during advancement likely contributed to the noted stretched guide wire exit notch.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

Event Description

It was reported that the procedure was to treat an aneurysm at the distal right coronary artery.A pilot 50 guide wire was advanced and a 2.5x15mm non-abbott balloon was used to pre-dilate the lesion, but was unable to fully expand the vessel.The non-abbott balloon was changed to a 2.75x15mm nc trek balloon and was dilated several times, but there was still about 20% of residual stenosis.A 2.8x16mm rx graftmaster was advanced but failed to cross due to anatomy.Ultimately, it was decided to use medicine for treatment.There was no adverse patient effects and no clinically significant delay.No additional information was provided.Device analysis noted the guide wire exit notch was stretched for a length of 1 mm.

• 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: 11599267
• MDR Text Key: 244287533
• Report Number: 2024168-2021-02579
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: H000001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 1012817-16
• Device Lot Number: 9032641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2019
• 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