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

Model Number	RSINT25018UX
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis summary: the stent was positioned on the balloon between the marker bands as per specifications.There was no evidence of deformation to the stent.The proximal balloon pillow was intact with no evidence that balloon had been pressurized.A kink was visible on the distal shaft proximal to the distal tip.The hypotube was oval and uneven at the detachment site.The distal tip was badly flared.Kinks were visible on the hypotube.Crystallized residue was visible in the inflation lumen.Negative prep did not detect a leak possibly due to the presence of residue in the inflation lumen.The balloon was inflated to nominal pressure with no issues noted and maintained pressure.(b)(4).
Event or Problem Description
The physician intended to use a resolute integrity drug eluting stent to treat a non-tortuous, non-calcified lesion with 85% stenosis in the mid circumflex artery.The lesion was pre-dilated.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop.The device was inspected with no issues.Negative prep was performed with no issues.It is reported that the stent went into the circumflex with no issues but the balloon would not inflate on the first inflation during stent deployment.The physician removed the stent delivery system to inspect and noted that the contrast was leaking from the catheter proximal to the stent but before the rx portion of the device.There was no resistance observed during delivery or withdrawal of the device from the lesion site and no excessive force was used.During inspection of the device the distal hub of the catheter broke off (outside the patient¿s body).The procedure was completed using another resolute integrity device of the same size.There is no patient injury.

• Brand Name: RESOLUTE INTEGRITY RX
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6867902
• Report Number: 9612164-2017-01271
• Device Sequence Number: 11114706
• Product Code: NIQ
• UDI-Device Identifier: 00643169037373
• UDI-Public: 00643169037373
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P110013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/10/2019
• Device Model Number: RSINT25018UX
• Device Catalogue Number: RSINT25018UX
• Device Lot Number: 0008531127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2017
• Initial Report FDA Received Date: 09/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1