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); Cardiac Arrest (1762); Perforation (2001); Respiratory Failure (2484); Pericardial Effusion (3271)

Event Date 02/02/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Udi #: the udi is unknown because the part and lot numbers were not provided.Concomitant medical products: dilatation catheter: nc trek 2.25x15.Stent: 3.5x28 and 2.25x18 xience sierra.The device was not returned for evaluation.A review of the lot history record of the reported lot could not be conducted because the part and lot numbers were not provided.A conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined.The reported patient effects of angina, death and perforation are listed in the nc trek rx, global, instructions for use as known patient effects.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The two graftmaster devices referenced are being filed under separate medwatch reports.

Event Description

It was reported that a kissing balloon technique was performed at the bifurcation of the proximal left anterior descending (lad) coronary artery and the diagonal artery for post dilatation.The 3.5x15 mm nc trek was used in the lad and the 2.25x15 mm nc trek was used in the diagonal branch.Both treks were inflated at 16 atms.After the treks were removed, the patient had worsening chest pain and a perforation was noted in the proximal lad.The 3.5x15 mm nc trek was re-advanced to the proximal lad and inflated for 12 atms.The patient condition rapidly deteriorated.Pericardial drainage was performed removing 100 to 150 cc of blood.The patient went into cardiac arrest and resuscitation was performed along with intubation for mechanical ventilation.While the patient was being resuscitated, the first 3.5x19 mm graftmaster stent was implanted to treat the lad perforation, but it did not seal the perforation.After the second graftmaster was implanted, there was a continued leak in the perforation which was treated with prolonged balloon inflation.The perforation was successfully sealed, but resuscitation attempts for more than twenty minutes were unsuccessful.The patient expired.No additional information was provided.

• 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: 8582231
• MDR Text Key: 144136553
• Report Number: 2024168-2019-03552
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/06/2019

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2019
• Initial Date FDA Received: 05/06/2019
• 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
• Patient Age: 90 YR
• Patient Weight: 63