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

Model Number	INT30030UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 or Problem Description
The physician intended to use a integrity bare-metal stent to treat a lesion located in the proximal left main (lm) coronary artery, circumflex (cx) artery and the obtuse marginal (om).The lesion was reported to be severely tortuous and severely calcified with (b)(4) stenosis.It was reported that there was a sharp 90 degree bend from left main into the circumflex.No damage was noted to packaging and no issues were noted when removing the devices from packaging.The devices were inspected with no issues identified.Negative prep was also performed with no issues.The 3.0 x 30 integrity was attempted first.The lesion was not pre-dilated and the stent did not pass through a previously deployed stent but resistance was encountered during advancement.It was reported that the stent did not cross the lesion and after it was removed from the body a stent strut on the proximal end was noted to be bent out.A 3.0 x 18 integrity was then used in case a shorter stent would be able to cross.No difficulties were noted when removing the protective sheath.The lesion was not pre-dilated.The device did not pass through a previously deployed stent but resistance was encountered when advancing the device.The inflation device remained on neutral pressure during delivery of the device.The stent could not cross the lesion.After the delivery system was removed from the circumflex, it was noted that the stent was still in the left main to circumflex and om.The dislodged stent was removed by snare.The lesion was left untreated.
Additional Manufacturer Narrative
The device was returned for analysis.Kinks were evident along the hypotube.The stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 32nd distal stent wrap with struts raised and overlapping.Deformation was evident to the distal tip.The procedural images captured treatment of the rca with unidentified devices.There are no images capturing the attempted delivery, dislodgement and subsequent removal of the integrity 3.0x18mm delivery system.The dislodged stent is visible in the vessel and is subsequently removed by a snare device.There are no images capturing the attempted delivery, deformation and subsequent removal of the integrity 3.0x30mm device.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 6586899
• Report Number: 9612164-2017-00620
• Device Sequence Number: 13740382
• Product Code: MAF
• UDI-Device Identifier: 00613994798534
• UDI-Public: 00613994798534
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/03/2017

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: 01/03/2019
• Device Model Number: INT30030UX
• Device Catalogue Number: INT30030UX
• Device Lot Number: 0008435428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2017
• Initial Date Received by Manufacturer: 04/25/2017
• Supplement Date Received by Manufacturer: 07/03/2017; 07/03/2017
• Initial Report FDA Received Date: 05/24/2017
• Supplement Report FDA Received Date: 08/01/2017; 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 140