MAUDE Adverse Event Report: MEDTRONIC IRELAND INTEGRITY RX; STENT, CORONARY

Model Number	INT25026UX
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During a procedure, an attempt was made to use two integrity rx coronary stent systems to treat a non-tortuous, non-calcified lesion exhibiting 95% stenosis in the mid left anterior descending (lad) artery.There was no damage noted to the devices packaging.There was no issues noted when removing the devices from the hoop.The devices were not inspected before use.Negative prep was performed with no issues noted.The lesion was pre-dilated prior to using the stent with lot number 0009829389.The lesion was not pre-dilated prior to using the stent with lot number 0009900545.The devices did not pass through a previously deployed stent.Resistance was not encountered when advancing the devices.Excessive force was not used during delivery.It was reported that the stents may not have been on the catheter prior to use.It was stated that there is no evidence of the stents in the vessel post balloon inflation.It was noted that several other integrity stents were placed after the first two stents were allegedly deployed and these stents are visible in the vessel.The patient was reported to be alive with no injury.
Additional Manufacturer Narrative
Product analysis cine image: coronary angiography (cag) of the left coronary system confirms the present of a chronic total occlusion (cto) of the proximal lad.There was no evidence of major lesions in the rca or lcx.A number of wires and devices were advanced through the guide catheter.There was difficulty delivering the wires across the occlusion in the lad.Poor flow was restored once the guidewires were delivered to the distal vessel.There were no images provided showing the attempted delivery of any devices.But subsequent images appear to show the successfully deployment of stents in the proximal vessel.There is no evidence of dislodged stents in the images provided.Therefore, the location for the integrity stents is unknown based on the images provided.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: there were no difficulties noted when removing the protective sheath for both devices.It was later reported that the sheaths of both devices were not inspected to determine whether the stents were removed upon removal of the sheaths and stylettes.The devices were prepared and sheaths were removed by a new member of staff.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTEGRITY RX
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9933109
• Report Number: 9612164-2020-01502
• Device Sequence Number: 17081898
• Product Code: MAF
• UDI-Device Identifier: 00613994798800
• UDI-Public: 00613994798800
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P030009
• 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,Followup,Followup
• Report Date (Section B): 07/15/2020

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: 07/14/2021
• Device Model Number: INT25026UX
• Device Catalogue Number: INT25026UX
• Device Lot Number: 0009829389
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/03/2020
• Supplement Date Received by Manufacturer: 04/07/2020; 07/07/2020
• Initial Report FDA Received Date: 04/07/2020
• Supplement Report FDA Received Date: 04/21/2020; 07/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 70