MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number 1012274-30

Device Problems Unintended System Motion (1430); Difficult to Remove (1528); Material Separation (1562); Failure to Deflate (4060)

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Cardiogenic Shock (2262); Obstruction/Occlusion (2422); Foreign Body In Patient (2687)

Event Date 02/02/2022

Event Type  Death  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported the procedure was to treat an in-stent restenosis in the circumflex coronary artery.The in-stent restenosis was treated with two balloon inflations.While in the circumflex artery, a moderately calcified and moderately tortuous lesion was noted in the left anterior descending (lad) artery with intravascular ultrasound (ivus).A trek rx 3 x 30mm balloon delivery catheter (bdc) was prepped (air aspiration) outside the anatomy and was then inserted and was inflated.Then it was noted there was no flow in the circumflex artery and the patient experienced an increased heart rate and a drop in blood pressure.The physician decided to remove the bdc; however, it was noted the balloon would not deflate and resistance was felt.The balloon shaft was removed and it was observed the balloon had completely dislodged from the shaft and was observed in the left main coronary artery.Shortly after this occurred, the patient coded and then passed away.It was suspected this was caused by the dislodged bdc.No additional information was provided.

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported the procedure was to treat an in-stent restenosis in the circumflex coronary artery.The in-stent restenosis was treated with two balloon inflations.While in the circumflex artery, a moderately calcified and moderately tortuous lesion was noted in the left anterior descending (lad) artery with intravascular ultrasound (ivus).A trek rx 3 x 30mm balloon delivery catheter (bdc) was prepped (air aspiration) outside the anatomy and was then inserted and was inflated.Then it was noted there was no flow in the circumflex artery and the patient experienced an increased heart rate and a drop in blood pressure.The physician decided to remove the bdc; however, it was noted the balloon would not deflate and resistance was felt.The balloon shaft was removed and it was observed the balloon had completely dislodged from the shaft and was observed in the left main coronary artery.Shortly after this occurred, the patient coded and then passed away.It was suspected this was caused by the dislodged bdc.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.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.The reported patient effects of hypotension, occlusion and death are listed in the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, instructions for use as known patient effects.The event was reviewed by an abbott medical reviewer.This was a case to treat a 70 year-old male patient with an in-stent restenosis of the left circumflex (lcx) artery.Without cine images, the device returned to review, or consistent procedural details disclosed, it is hard to determine how the balloon came off the catheter, if it remained inflated after removal of the balloon catheter, or what may have led to this patient¿s death.The patient was in a compromised state prior to the balloon dilatation catheter being removed.The cause of the lcx artery to not have any blood flow is unknown.Due to the lack of information, it cannot be definitively stated that the 3.0 x 30mm trek bdc was the direct cause of death, though it was most likely an indirect cause of this patient¿s death.The investigation was unable to determine a conclusive cause for the reported failure to deflate; however, the reported difficulty removing the device, shaft separation, unintended system motion, unexpected medical intervention, medication requirement and foreign body in patient appear to be related to circumstances of the procedure.Furthermore, as stated in the medical review, ¿without cine images, the device returned to review, or the complete correct procedural events disclosed, it cannot be definitively stated that the 3.0 x30mm trek bdc was the direct cause of death, though it was most likely an indirect cause of this patient¿s death.¿ therefore, a conclusive cause for the reported patient effects of bradycardia, tachycardia, cardiac arrest, hypotension, obstruction/occlusion, cardiogenic shock and death and the relationship to the device, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Attachment: maude report medwatch # mw5107513.

Event Description

It was reported the procedure was to treat an in-stent restenosis in the circumflex coronary artery.The in-stent restenosis was treated with two balloon inflations.While in the circumflex artery, a moderately calcified and moderately tortuous lesion was noted in the left anterior descending (lad) artery with intravascular ultrasound (ivus).A trek rx 3 x 30mm balloon delivery catheter (bdc) was prepped (air aspiration) outside the anatomy and was then inserted and was inflated.Then it was noted there was no flow in the circumflex artery and the patient experienced an increased heart rate and a drop in blood pressure.The physician decided to remove the bdc; however, it was noted the balloon would not deflate and resistance was felt.The balloon shaft was removed and it was observed the balloon had completely dislodged from the shaft and was observed in the left main coronary artery.Shortly after this occurred, the patient coded and then passed away.It was suspected this was caused by the dislodged bdc.Subsequent to the initially filed report, the following information was provided: the separation occurred proximal to the balloon, on the shaft.Approximately the distal 2/3 of the catheter broke off.Residual contrast was left in the partially inflated balloon when the physician attempted to pull back.The physician then injected contrast to take a picture and it was noted that the balloon jumped forward due to the injection of contrast.Attempt was made to puncture the balloon with a needle or needles and to snare the balloon with a hooked device, none of which were successful.The balloon was left inside the patient's artery.The autopsy finding showed that the broken balloon system was left in the patient's artery.Subsequent to the initially filed report, the following information was provided via the fda maude database which was provided by the account when they initially reported the incident to the fda: "we then repositioned our wire down the lad and performed intravascular ultrasound to the lad showing a probable greater than 70% stenosis.At the time of lad ultrasound the patient became acutely ill with chest pain, some bradycardia and hypotension.Angiogram was performed and there was no flow in our circumflex where we had performed angioplasty.We rewired the circumflex, went back down with a 3.0 balloon and performed balloon inflations with some improvement in flow.I then went in with a longer 3.0 x 30 balloon and once again performed balloon inflation.About this time, the patient developed cardiac arrest with bradycardia.He was treated with atropine and epinephrine but unfortunately did not really respond.The long 3.0 balloon was removed and, at the time of removal, the balloon came off the shaft and became lodged in the proximal circumflex and into the left main.Over the course of 30 minutes we made numerous attempts to retrieve the balloon with a snare with different devices to try to puncture the balloon or sandwich the balloon into the guide for removal, with no success, continued cpr and acls resuscitation was performed and the patient was intubated.An impella was placed in the right groin at our previous angiogram cath site and then access was obtained in the left groin for continued attempts to retrieve the balloon.After a considerable amount of time of cpr resuscitation and no success in balloon retrieval, the procedure was discontinued and the patient was pronounced, overall cause of death is cardiogenic shock from cardiac arrest due to coronary balloon lodging in the left main." no additional information was provided.

• Brand Name: TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13581700
• MDR Text Key: 285980571
• Report Number: 2024168-2022-01891
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138461
• UDI-Public: 08717648138461
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/28/2022

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: 02/29/2024
• Device Model Number: 1012274-30
• Device Catalogue Number: 1012274-30
• Device Lot Number: 10330G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2022
• Initial Date FDA Received: 02/22/2022
• Supplement Dates Manufacturer Received: 04/05/2022
• Supplement Dates FDA Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• 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
• Patient Outcome(s): Death
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 79 KG