MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDEAVOR SPRINT RX; STENT, CORONARY, DRUG-ELUTING

Lot Number UNKNOWN

Device Problem Fracture (1260)

Patient Problems Stenosis (2263); Injury (2348)

Event Date 04/01/2008

Event Type  Injury  

Manufacturer Narrative

"fracture of zotarolimus-eluting stent after implantation." tex heart inst j 2009; 36 (6): 618-20.Still procedural image review- cineangiography reveals a grade iv fracture in the endeavor stent.Coronary angiography reveals in-stent restenosis at a bifurcation of the left anterior descending coronary artery.Implant date: month and year valid.Date of event: month and year valid.If information is provided in the future, a supplemental report will be issued.

Event Description

An endeavor sprint rx zotarolimus eluting stent was used to treat a bifurcated lad lesion.The lesion was pre-dilated with a sprinter rx balloon catheter at 8atm.The endeavor sprint stent was deployed at 12atm.The ostial stenosis of the diagonal branch was dilated again with a sprinter balloon with good results reported.Approximately 10 months later the patient again experienced angina.Angio revealed stent fracture grade iv that was associated with in-stent restenosis.Kissing balloon technique was used to treat the bifurcation using two sprinter balloons.It was reported that the patients clinical symptoms improved and remained stable on follow up.

• Brand Name: ENDEAVOR SPRINT RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8586631
• MDR Text Key: 144279171
• Report Number: 9612164-2019-01604
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P060033
• 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
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2019
• 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: 78 YR