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

Catalog Number 1012273-20

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problems Angina (1710); Occlusion (1984); Thrombosis (2100)

Event Date 05/12/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. 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 lot number was not provided. The reported patient effects of angina and occlusion, as listed in the coronary dilatation catheter, trek rx instructions for use are known patient effects that may be associated with use of a coronary catheter in native coronary arteries. The investigation was unable to determine a conclusive cause for the reported deflation issue. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device. The xience alpine referenced in describe event or problem and concomitant medical products is filed under a separate medwatch report number.

Event Description

It was reported that the procedure was to treat an acute myocardial infarction patient who came to the emergency department in the middle of the night on (b)(6) 2017. The patient previously had the left anterior descending coronary artery (lad) stented on (b)(6) 2017. When the patient arrived, the diagonal was shutting down so they direct stented with an unknown xience alpine stent. Then, the trek rx 2. 75 x 20 mm balloon dilatation catheter was used to post-dilate the lesion at 11 atmospheres, however the balloon would only partially deflate. There was difficulty extracting the balloon from the anatomy as it was only partially deflated and this was completely blocking flow which made the patient experience chest pain. An over the wire non-abbott balloon was loaded on the guide wire backwards in an attempt to feed and poke/burst the trek rx balloon in an attempt to deflate it, but this was unsuccessful. Trek rx balloon was ultimately withdrawn from the anatomy partially deflated with negative pressure being held the entire time. After the balloon was removed from the anatomy, thrombus was noted in the lad and diagonal, with the circumflex partially shut down. The physician used an aspiration catheter successfully to restore blood flow. Afterwards, a kissing balloon technique was used in the diagonal and lad to successfully re-open. An non-abbott heart pump was used to stabilize the patient and patient was discharged the next day. No additional information was provided.

• Brand Name: 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: 6637251
• MDR Text Key: 77450098
• Report Number: 2024168-2017-05021
• 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

• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 1012273-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/22/2017
• 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 Treatment Data

Date Received: 06/13/2017 Patient Sequence Number: 1

Treatment

STENT - XIENCE ALPINE