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

Model Number 1012580-16

Device Problems Deflation Problem (1149); Entrapment of Device (1212); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Device Damaged by Another Device (2915)

Patient Problem Pain (1994)

Event Date 06/24/2018

Event Type  Injury  

Manufacturer Narrative

Initial reporter occupation: (b)(6).The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The trek balloon dilatation catheter referenced is filed under a separate medwatch report number.

Event Description

It was reported that on (b)(6) 2018, the patient presented with myocardial infarction.Angiography noted 100% occlusion in the circumflex (cx) artery.The distal cx was treated with pre-dilatation, using a 2.0 x 20 mm mini trek rx dilatation catheter, and stenting with a 2.5 x 38 mm non-abbott stent.Post-dilatation was performed using a 2.0 x 12 mm mini trek rx dilatation catheter.The lesion in the mid cx was treated with pre-dilatation, using a 2.0 x 20 mm mini trek dilatation catheter and stenting with a 3.0 x 34 m non-abbott stent.The lesion in the proximal cx treated with pre-dilatation, using a 2.0 x 12 mm mini trek rx dilatation catheter and a 3.0 x 12 mm trek rx dilatation catheter, and stenting with a 3.0 x 12 mm non-abbott stent.Post-procedure angiography showed evidence of distal perforation.Echocardiography showed a small pericardial effusion.Anticoagulation was discontinued.The perforation was treated with prolonged balloon inflation proximal to the perforation; however, this was unsuccessful.This was followed by advancement of the 2.8 x 16 mm graftmaster stent delivery system (sds); however, the graftmaster sds could not be advanced to the site of the perforation.The device could not be retracted nor removed, so the stent was deployed at what appeared to be a safe site.Post deployment of the stent, the physician was unable to retract the stent balloon from the covered stent.A non-abbott guide catheter extension was advanced immediately proximal to the covered stent to provide extra support, but the sds/balloon could not be removed from the vessel.A second guide wire was inserted and an attempt was made to advance the wire through the stent, adjacent to the stent balloon; this was unsuccessful.Any attempt to remove the sds appeared to "accordion" the implanted stents.The physician was unable to determine if the covered stent balloon had deflated.Cardiothoracic surgical consult was obtained and the patient was taken for surgical removal of the device.The surgical procedure was performed the same day.The patient was placed on cardiopulmonary bypass.The stented area was stabilized and the stent delivery system was pulled.The balloon disengaged from where it was trapped and was easily pulled out.The patient's heart appeared to be functioning well and the patient tolerated the procedure well.Three chest tubes were placed.The patient was taken to the intensive care unit in satisfactory condition.Post-operatively, the chest tubes were removed once draining.A small pneumothorax was seen, but was stable once the chest tubes were removed.The patient was discharged to home on (b)(6) 2018, with home health nurse visits.On (b)(6) 2018, the patient was seen by the home health nurse and was found to be hypotensive.The patient had complaints of feeling sleepy and generalized weakness.The patient was re-hospitalized for further evaluation.Aspirin and normal saline bolus were administered, and the blood pressure improved.No changes were noted on electrocardiogram, but troponin levels were elevated, likely related to previous myocardial infarction.The hypotension was thought to be medication related and the patient's medications were adjusted.On (b)(6) 2021, the patient was seen with complaints of chest wall tenderness.The patient reported healing well from the initial surgery; however, the pain never resolved.The patient reported the pain was not anginal in nature, but felt it was related to the sternal wires.Additionally, a keloid was present at the incision site.A surgical procedure was performed on (b)(6) 2021, with excision of the keloid and removal of the sternal wires.The patient tolerated the surgical procedure well and was taken to the recovery area in satisfactory condition.No additional information was provided.

Manufacturer Narrative

Medical device problem code 2017- failure to follow steps / instructions.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history did not indicate a lot specific quality issue.Abbott medical affairs reviewed the reported event and concluded that there may have been other reasons that the stent was unable to be removed from the vessel prior to deployment in the mid-lcx, however without the cine films to review, it cannot be definitely stated why the stent graft, nor why the stent graft balloon could not be removed.One possible scenario is that the 2.8mmx16mm graftmaster stent was oversized for this patients¿ distal lcx and therefore unable to cross the distal stent, as the distal medtronic resolute onyx stent that was placed there was a 2.5mmx28mm and deployed at the nominal rate of 12atm, leaving the stent size at 2.5mm.There may have been other reasons that the stent was unable to be removed from the vessel prior to deployment in the mid-lcx, however without the cine films to review, it cannot be definitely stated why the stent graft, nor why the stent graft balloon could not be removed.One thing is for certain that the graftmaster in this case was used to treat the perforation in the lcx and it was not the cause of the perforation.The entrapment of the graftmaster was due to procedural complications and since the product was not returned for analysis, a device investigation cannot be performed.It was reported that the graftmaster was deployed with a max pressure of 11 atmospheres (atm).It should be noted that the graftmaster rapid exchange (rx) coronary stent graft system, domestic, instructions for use (ifu) states; deploy the stent graft slowly by pressurizing the delivery system in 2-atm increments, every 5 seconds, until the stent graft is completely expanded.Fully expand the stent graft by inflating to nominal pressure at a minimum.The ifu, specifies the nominal rated burst pressure (rbp) is 15 atmospheres (atm); thus the stent was not expanded to nominal pressure and not fully expanded.It is unknown if the ifu deviation contributed to the reported event.The reported patient effect of pain is listed in the ifu as a known patient effect that may be associated with use of a coronary stent in native coronary arteries.The investigation determined the reported entrapment of device, device damaged by another device and subsequent treatments appear to be related to circumstances of the procedure.The investigation was unable to determine a conclusive cause for the reported failure to advance and deflation problem.A conclusive cause for the reported patient effects, 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.

• 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
• MDR Report Key: 11803557
• MDR Text Key: 250376927
• Report Number: 2024168-2021-03966
• Device Sequence Number: 1
• Product Code: MAF
• UDI-Device Identifier: 08717648176340
• UDI-Public: 08717648176340
• Combination Product (y/n): N
• PMA/PMN Number: H000001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: 1012580-16
• Device Catalogue Number: 1012580-16
• Device Lot Number: 7020841
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RESOLUTE ONYX STENTS (2.5X38MM, 3.0X34MM, 3.0X12MM)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 73