MAUDE Adverse Event Report: MEDTRONIC MEXICO SPRINTER LEGEND RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Catalog Number UNK-CV-GWY-NCEUPX

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

Patient Problem Vascular Dissection (3160)

Event Date 08/18/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

During a procedure, two resolute onyx rx coronary drug eluting stents were used to treat a moderately tortuous, moderately calcified lesion located in the left anterior descending (lad) artery and diagonal branch. It was later stated that the stents were used to cover a dissection caused by ballooning the ostium of the diagonal, which was exhibiting around 50% stenosis. The devices were inspected with no issues noted. Negative prep was not performed. The lesion was pre-dilated. The devices did pass through a previously deployed stent. Resistance was encountered when advancing the devices. Aggressive but not excessive force was used with both devices during delivery. It was reported that the resolute onyx stent (pli 10, lot 0009833921) dislodged during delivery in the lad while attempting to deliver the stent to the diagonal branch. It was stated that both stents flared when trying to pass a stent in order to advance into the diagonal branch and was jailed by another stent that was deployed across the diagonal branch. Another stent was used to crush the dislodged stent into the wall of the mid lad. It was also reported that the second resolute onyx stent (pli 20, lot 0009983738) deformed in vivo during positioning. It was stated that the physician completed the procedure using another stent. It was later reported that it is thought that the dissection occurred due to ballooning the ostium of the diagonal using a medtronic device. The patient was reported to be alive with no further injury.

• Brand Name: SPRINTER LEGEND RX
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 10586270
• MDR Text Key: 208526959
• Report Number: 9612164-2020-03636
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P790017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK-CV-GWY-NCEUPX
• 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: 01/20/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• 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: 09/25/2020 Patient Sequence Number: 1