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

Catalog Number INT25018X

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2017

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: kinks were evident along the hypotube.The device had not been inflated.Blood was visible in the balloon and inflation lumen.The device was placed in the waterbath.On removal from the waterbath, the device failed negative prep.On pressurisation of the device, a leak was observed on the balloon proximal pillow.Upon visual inspection of the device, a short longitudinal tear was visible on the balloon proximal pillow.The balloon material was raised, jagged and uneven at the tear site.A lead in scratch was visible proximal to the tear site.(b)(4).

Event Description

It was reported that the physician attempted to use one 2.50 mm x 22 mm integrity rx stent and two 2.50 mm x 18 mm integrity rx stents to treat a non- calcified, 70-80% stenosis and non-tortuous mid cx lesion.It was reported that negative prep was not performed on the devices.The target lesion was not pre-dilated.No resistance was encountered when advancing any of the devices and no excessive force was used all three devices were inspected prior to use with no issues noted.The same inflation device was used with all devices.All three devices failed to inflate completely when 16 atms of pressure was applied.The account reported that the vessel morphology was not a contributing factor and that the issue was not due to the inflation pressure applied.The devices were not implanted.No patient injury reported.The procedure was completed with another integrity device.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTEGRITY RX
• Type of Device: STENT, CORONARY
• 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: 6408790
• MDR Text Key: 70060163
• Report Number: 9612164-2017-00282
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: RO
• PMA/PMN Number: P030009
• 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
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2017
• Device Catalogue Number: INT25018X
• Device Lot Number: 0007856401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2013
• 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: 78 YR
• Patient Weight: 75