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

Catalog Number RSINT27526X

Device Problem Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2016

Event Type  malfunction  

Event Description

It was reported that the physician was attempting to use a resolute integrity rx drug eluting stent to treat a proximal lad lesion.No damage noted to device packaging and no issues were noted when removing the devices from the hoop/tray.The device was inspected with no issues noted.It was reported that the lesion was not pre-dilated.During the procedure it was reported that the device did not pass through a previously deployed stent.No resistance was encountered or excessive force used.It was reported that the physician attempted to inflate the device at nominal pressure (9atms) but the device would not inflate at all.The inflation device was check and confirmed to be working after inflating another balloon.After removal, the physician attempted to inflate the stent on the table and it would not inflate.No patient injury reported.The physician successfully completed the procedure using another resolute integrity stent.

Manufacturer Narrative

There were a number of kinks visible along the hypotube.The stent was correctly positioned on the delivery system balloon with no evidence of attempted expansion.The balloon pillow and shoulder folds were intact.Negative prep was performed with no issues noted.The balloon was inflated to nominal pressure (9 atms) with no issues noted and maintained pressure.The support mandrel was removed to with no leaks detected on the inner distal shaft.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: 6188677
• MDR Text Key: 62851096
• Report Number: 9612164-2016-01337
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P110013
• 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,Followup
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2018
• Device Catalogue Number: RSINT27526X
• Device Lot Number: 0008011372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2016
• 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 Age: 76 YR