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

Catalog Number 1012817-16

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616); Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923); Activation Failure (3270)

Patient Problems Myocardial Infarction (1969); Device Embedded In Tissue or Plaque (3165); Thrombosis/Thrombus (4440)

Event Date 06/15/2022

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a perforation in the sidebranch of the distal left anterior descending (lad) artery.A 2.8x16mm rx graftmaster (gm) was advanced to the lesion and deployment was initiated.The covered stent was attempted a couple times to be deployed at 12 atmospheres but failed to inflate/deploy.The device was then decided to be removed and during removal resistance was met with the previously implanted non-abbott stent in the mid-lad as it became caught.The gm stent implant dislodged (still remaining partially on the balloon and delivery system).Physician decided to deploy the gm stent at the non-target mid-lad vessel at 20 atmospheres but the stent implant did not fully appose to the vessel wall.Additional dilatation with an unspecified balloon was performed to fully embed the stent in the vessel.Coils were used to treat the sidebranch perforation successfully.Two hours after the gm was implanted, the patient was symptomatic with myocardial infarction and via angiography in-stent thrombosis was confirmed.Revascularization in another percutaneous coronary intervention was performed to treat the thrombosis.Afterwards, patient was sent to the intensive care unit for recovery.No additional information was provided.

Manufacturer Narrative

(b)(4).The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

The device was not returned for analysis.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 similar incidents from this lot.It was reported that the graftmaster rx covered stent delivery system was attempted to be placed distal of the previously implanted stent.It should be noted that the graftmaster rapid exchange (rx), coronary stent graft system, instructions for use, (ifu) states: if more than one stent graft is required, the distal stent graft should be placed initially, followed by placement of the proximal stent graft.Stent graft placement in this order obviates the need to cross the proximal stent graft when placing the distal stent graft and reduces the chances for dislodging the proximal stent graft.It was also reported that the graftmaster was deployed with a maximum pressure of 20 atmospheres (atm).The graftmaster rapid exchange (rx), coronary stent graft system, instructions for use, (ifu) specifies the rated burst pressure (rbp) is 16 atm and clearly states not to exceed the rbp as indicated on the product label.The reported patient effects of myocardial infarction and thrombosis, as listed in the graftmaster rapid exchange (rx), coronary stent graft system, instructions for use (ifu), are known patient effects that may be associated with use of a coronary stent in native coronary arteries.A conclusive cause for the reported activation failure including expansion failures could not be determined.The investigation determined the reported stent dislodgement, difficult to remove, malposition of device and patient-device incompatibility in addition to the subsequent treatments including device embedded in tissue or plaque appear to be related to the operational context of the procedure.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling of the device.

• 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: 15027750
• MDR Text Key: 295969999
• Report Number: 2024168-2022-07723
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: H000001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 1012817-16
• Device Lot Number: 1042941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2022
• Initial Date FDA Received: 07/15/2022
• Supplement Dates Manufacturer Received: 08/03/2022
• Supplement Dates FDA Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2021
• 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: SYNERGY STENT
• Patient Outcome(s): Disability; Required Intervention; Hospitalization