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

Catalog Number NCSP3012X

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

Patient Problem Vascular Dissection (3160)

Event Date 12/22/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

An attempt was made to use one resolute onyx rx coronary drug eluting stent to treat a moderately tortuous, severely calcified lesion exhibiting 70-90% stenosis located in the mid lad.The device was inspected with no issues.Negative prep was not performed.The lesion was pre-dilated using a sprinter legend and nc sprinter balloon.The device passed through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was used during delivery.It was reported that the stent failed to cross the lesion and then dislodged into the proximal lad during delivery to/at the lesion.The inflation device remained on neutral pressure during delivery of the dislodged device.A balloon was inserted and inflated to deploy the dislodged stent, the dislodged stent was attached to the previously deployed proximal stent.The target lesion was left untreated.It was indicated that a small dissection occurred, it was reported that the physician believes that the dissection was not caused by a medtronic stent but may have occurred due to pre-dilation balloons.The dissection was left untreated.

Manufacturer Narrative

Procedural images: the images capture a lesion site in the lad, with severe calcification evident throughout the proximal lad.Pre-dilation is captured with two balloon devices, possibly the sprinter legend and nc sprinter balloons.A stent is then deployed in the proximal lad.A second stent is then deployed in the proximal lad.The shape of the deployed stent indicates the stent is conforming to the calcification in the vessel.A cloud of contrast next to the deployed stent in the proximal lad suggests this is the site of the reported dissection.The next image captures the dislodged resolute onyx stent within the previously deployed stent in the lad.A balloon device is also visible in the mid lad.The partial inflation of this balloon device is then evident within the previously deployed stent.A balloon device is then inflated at the site of the dislodged stent.No further treatment was evident from the images.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NC SPRINTER 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: 8257810
• MDR Text Key: 133387912
• Report Number: 9612164-2019-00222
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: P790017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2019
• Device Catalogue Number: NCSP3012X
• Device Lot Number: 214351461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2019
• Date Device Manufactured: 11/07/2017
• 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): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 50