MAUDE Adverse Event Report: AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER

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

Patient Problems Angina (1710); Bradycardia (1751); Cardiac Arrest (1762); Death (1802); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Respiratory Failure (2484)

Event Date 06/01/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The udi is unknown because the part number and lot number were not provided.Patient weight: (b)(6).The patient expired due to hemodynamic collapse on (b)(6) 2016.No additional information was provided.Concomitant medical devices: guide wire: runthrough; guide catheter: 6-french mp-2; embolic protection: 3.0 spider.The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot numbers were not provided.The reported patient effects of angina, death, hypotension and perforation are listed in the coronary dilatation catheters (cdc), nc trek rx, global , instructions for use, as known patient effects.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the patient presented with 70 to 80% narrowing in the mid to distal saphenous vein graft (svg) to distal right coronary artery (rca).With a non-abbott 6fr guiding catheter, non-abbott guide wire, and a non-abbott embolic protection device positioned in the distal vessel area, balloon angioplasty was performed using a 3.5x20mm non-compliant (nc) trek balloon dilatation catheter (bdc); during angioplasty, the patient experienced chest pain, bradycardia, and relative hypotension.After the 3.5x20 trek balloon was deflated, a perforation with contrast extravasation was observed.A 4.0x20mm nc trek bdc was then quickly advanced to the perforation site and multiple prolonged inflations were performed to help tamponade this perforation; during this balloon tamponade, the patient began to experience hemodynamic deterioration and essentially experienced bradycardic arrest.The patient was successfully resuscitated with full advanced cardiac life support protocol and intubation.Once the patient regained some hemodynamic stability, a 4.0x19mm rx graftmaster covered stent was advanced to the perforation and was deployed with a maximum pressure of 16 atmospheres, sealing the perforation; the coronary intervention result was quite good.While the heart rhythm remained stable, the patient remained hypotensive.At this point, a non-abbott pump was implanted in the left ventricle without difficulty and full support was initiated.At this point, the patient was in a critical and guarded condition on full ventilatory and left ventricular support.The patient was transferred to the intensive care unit, where the patient condition continued to deteriorate into multi organ failure.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5751726
• MDR Text Key: 48242701
• Report Number: 2024168-2016-04145
• Device Sequence Number: 1
• Product Code: LOX
• 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: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Hospitalization
• Patient Age: 78 YR
• Patient Weight: 93