MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE INTEGRITY RX; STENT, CORONARY, DRUG-ELUTING

Catalog Number RSINT40038UX

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

Patient Problem Perforation (2001)

Event Date 05/31/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During a procedure a resolute integrity rx coronary, drug eluting stent was used to treat a lesion in the mid left anterior descending(lad) artery.The device was inspected with no issues noted.Negative prep was not performed.It is reported that an expired stent was implanted in the patient.The product expired on the 25th of may 2019.The patient is alive with no injury.No intervention as a result of expired product.However it was reported that the patient also received a rsint40038ux also in the mid lad.The patient was noted to have a perforation of the artery after second stent deployment.Two non-medtronic covered stents were placed in the mid lad during this case.Pt remained in the hospital over the weekend and returned to cath lab for repeat angiography.Patient was noted to have inadequate sealing of perforation.A 4.0 non-medtronic stent was placed, patient left lab in stable condition.Md that performed intervention states patient ¿doing well¿.

Manufacturer Narrative

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

• Brand Name: RESOLUTE INTEGRITY 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: 8757265
• MDR Text Key: 149920923
• Report Number: 9612164-2019-02670
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169037267
• UDI-Public: 00643169037267
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2019
• Device Catalogue Number: RSINT40038UX
• Device Lot Number: 0008780450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/04/2019
• Date Device Manufactured: 09/02/2017
• 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