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

Catalog Number RSINT35022UX

Device Problems Fracture (1260); Material Distortion (2977)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/28/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the physician was attempting to use an resolute integrity rx drug eluting stent to treat a severely calcified and tortuous proximal cx lesion with 90% stenosis.No damage was noted to the device packaging and no issues noted removing the device from the hoop/tray.The device was inspected with no issues noted.During the procedure it was reported that the device did not pass through a previously deployed stent.Resistance was encountered during delivery but no excessive force was used.It was reported that the device was placed and deployed successfully.The balloon of the device successfully deflated post stent deployment.No difficulty experienced when removing the guidewire.Balloon or delivery system did not snag on the deployed stent.It was reported that following the procedure, the patent returned with symptoms.An angiogram was performed and a focal lesion in the previously deployed stent was noted.The physician believes that the stent was fractured.The stent was then ballooned and a diencephalic stent was placed.

Manufacturer Narrative

Image review: the images capture the deployed stent prior to delivery and inflation of the balloon devices.The stent does appear to have conformed to the shape of the lesion.The stent appears to be intact with no fracture/break visible.A number of balloon inflations are performed and another stent is deployed on the proximal side.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

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: 5828770
• MDR Text Key: 50613408
• Report Number: 9612164-2016-00726
• Device Sequence Number: 1
• Product Code: NIQ
• 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,Followup
• Report Date: 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2018
• Device Catalogue Number: RSINT35022UX
• Device Lot Number: 0007889906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2016
• Date Device Manufactured: 01/11/2016
• 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