MAUDE Adverse Event Report: ABBOTT VASCULAR TREK RX CORONARY DILATATION CATHETER

Catalog Number 1012276-12

Device Problem Material Rupture (1546)

Patient Problems Intimal Dissection (1333); Air Embolism (1697); Bradycardia (1751); Cardiac Arrest (1762); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914)

Event Date 11/05/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the patient presented with severe multivessel coronary artery disease and the procedure was performed to treat a heavily calcified, stenosed lesion at the bifurcation of the left main artery into the ramus intermedius and circumflex artery.A 3.0x38 mm xience sierra stent was deployed successfully at 18 atmospheres at the left main to ramus intermedius artery.Post dilatation was then performed at the bifurcation using the kissing balloon (dilatation) technique with a non-compliant unspecified balloon dilatation catheter (bdc) and a 3.5 x12 mm trek bdc at 8 atmospheres.During inflation, the balloon of the trek bdc ruptured causing a dissection.The patient developed hypotension, bradycardia, and ultimately pulseless electrical activity.Medication was administered and cardiopulmonary resuscitation (cpr) was performed.Angiogram showed timi grade 0 flow.Air emboli was suspected and an air bubble was aspirated.Timi flow was restored back to grade 3 and the patient stabilized quickly.The patient was transferred to the intensive care unit.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001.The device was returned for analysis.The reported balloon rupture was confirmed.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 identified no other similar incidents/complaints from this lot.The reported patient effects of intimal dissection, embolism and hypotension are listed in the coronary dilatation catheters (cdc), trek rx and mini trek rx, global instructions for use, as known patient effects.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.The investigation determined the reported balloon rupture appears to be related to operational context as it is likely that the balloon interacted with the previously implanted stent such that the balloon became damaged and ruptured during inflation.A conclusive cause for the reported patient effects of intimal dissection, air embolism, bradycardia, cardiac arrest ekg/ecg changes and hypotension and the relationship to the product, if any, cannot be determined.

• Brand Name: TREK RX CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9370805
• MDR Text Key: 167857396
• Report Number: 2024168-2019-13878
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138560
• UDI-Public: 08717648138560
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 1012276-12
• Device Lot Number: 90731G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Date Manufacturer Received: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3.0 X 38 MM XIENCE SIERRA STENT; 3.0 X 38 MM XIENCE SIERRA STENT
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 92