MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Catalog Number UNK RX TREK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation of Vessels (2135); Pericardial Effusion (3271)

Event Date 06/24/2018

Event Type  Injury  

Manufacturer Narrative

Initial reporter occupation: (b)(6).The device is reportedly not returning.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The graftmaster stent system 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

The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of perforation is listed in the trek rx and mini trek rx coronary dilatation catheter instruction for use (ifu), as a possible adverse event.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11803520
• MDR Text Key: 250375509
• Report Number: 2024168-2021-03967
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: K103110
• 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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK RX TREK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 73