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

Catalog Number RSINT22518UX

Device Problems Difficult to Open or Remove Packaging Material (2922); Material Distortion (2977)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2017

Event Type  malfunction  

Manufacturer Narrative

Product analysis photo review: a photo provided by the account captured the damage to the distal end of the protective sheath.Product analysis summary: the sheath and stylette were returned loaded in the device.The stent was positioned on the balloon between the marker bands as per specifications.There was no deformation evident to the stent.There was no damage or material break evident to the distal tip.There was no damaged evident to the delivery system catheter.The sheath and stylette were removed from the device with no resistance noted.The tapered section of the sheath was severely bunched and deformed.There was no kinks or damage evident to the stylette.(b)(4).

Event Description

Physician intended to use a resolute integrity rx drug eluting stent.It was reported that there were no issues noted to the packaging, there were no issues noted when removing the device from the hoop/tray.The device was inspected and no issues were noted; no defects in appearance apparent prior to attempting the removal of the stylette or protective sheath.Resistance was noted when attempting to remove the protective stylette and it was stuck.The tech then tried a second time prior to tearing their glove.Their glove became snagged on the stylette and was stuck on the open area of the stylet loop and the protective sheath was resistant to removal and became misshapen.A break occurred at the tip.Negative prep was not performed.The device was not kinked and re straightened during use.Neither the tech or physician attempted to remove the protective sheath once the device had been contaminated.The device was not used in the patient as the torn glove contaminated the product so the team removed it from the table.The device was replaced with a non mdt product.

• 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: 6900363
• MDR Text Key: 87618378
• Report Number: 9612164-2017-01336
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169037427
• UDI-Public: 00643169037427
• 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
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2018
• Device Catalogue Number: RSINT22518UX
• Device Lot Number: 0007926086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2016
• 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