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

Catalog Number RSINT30015UX

Device Problems Inaccurate Delivery (2339); Device Dislodged or Dislocated (2923)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/12/2016

Event Type  Injury  

Manufacturer Narrative

Cine image review: the images capture the lesion site in the mid rca lesion exhibiting 95% stenosis as reported by the account.A previously deployed stent is visible in the proximal rca.The lesion site was pre-dilated with an unidentified balloon.The images appear to capture the possible attempted delivery of the resolute integrity 3.0 x 15mm stent.In the next images, the dislodged stent is clearly visible in the previously deployed stent in the proximal rca.The images however do not capture this dislodgement or the subsequent removal of the delivery system.A number of unidentified balloons are then used to jail the dislodged stent to the vessel wall and a subsequent stent is deployed.The reported deployment of the dislodged stent is not captured by the images com: (b)(4).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.

Event Description

It was reported that the physician was attempting to use a resolute integrity rx drug eluting stent to treat a moderately calcified and slightly tortuous mid rca lesion exhibiting 95% stenosis.It was reported that no issues were noted to the device packaging or issues encountered when removing the device from the hoop / tray.The device was inspected and negative prep performed with no issues noted.No issues noted when removing the protective sheath, the stent was inspected post removal of sheath with no issues noted.The lesion was pre-dilated.The stent passed through a previously deployed stent.The inflation device remained on neutral pressure during delivery of the device.Resistance was encountered while advancing the device but no excessive force used.It was reported that while maneuvering the stent through the previously deployed stent , the stent dislodged in the proximal rca.It was reported that the physician passed the balloon back through the stent and deployed the stent in the proximal rca.The proximal rca was then restented successfully with another 3.0x15mm resolute integrity stent.The physician then used a guideliner through both proximal stents and delivered a new stent to the original mid rca lesion successfully.Patient reported as well with no adverse events.

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: 6240278
• MDR Text Key: 64424559
• Report Number: 9612164-2017-00038
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169037502
• UDI-Public: 00643169037502
• 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: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2018
• Device Catalogue Number: RSINT30015UX
• Device Lot Number: 0008196077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2016
• Date Device Manufactured: 08/27/2016
• 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
• Patient Age: 80 YR
• Patient Weight: 81