MAUDE Adverse Event Report: MEDTRONIC MEXICO ADMIRAL XTREME; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	ADM060300130L
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2019
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
It was reported that the physician intended to use a protege everflex stent to treat a moderately calcified, moderately tortuous, chronic total occlusion(cto) 100% stenotic fibrous lesion in the mid/distal/proximal superficial femoral artery(sfa).The artery diameter and lesion length were reported to be 6mm <(>&<)> 300mm, respectively.The lesion was pre-dilated with a 6x300x130admiral xtreme balloon.There was no damage noted to the packaging and no issues noted when removing the balloon from the tray.The device was prepped without issue.A 7fr non-medtronic sheath along with a 0.035 non medtronic with no embolic protection.The device did not pass through a previously deployed stent no resistance was encountered nor excessive force applied when accessing the lesion.On first inflation to 6atm, the balloon burst.All fragments of the balloon were retrieved from the patient.A new 6x300 admiral xtreme balloon was used to complete the pre-dilation.The everflex stent was then introduced but it was reported that the stent got stuck on the 0.035 wire.The stent and wire had to be removed as a unit.The stent was reported to have flared at the distal tip.A new wire was then used to cross the lesion and a 6x150 everflex stent was deployed in the distal sfa.A 7x150 everflex stent was then placed in the mid sfa.The 6x300 admiral xtreme that was used for the pre-dilation was then used for post dilation.Post procedure angiogram looked good.There was no patient injury reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: the device was safely removed from the patient, a pinhole leak was reported.The stent and guidewire were safely removed as a unit.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ADMIRAL XTREME
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 8615790
• Report Number: 9612164-2019-01783
• Device Sequence Number: 2220374
• Product Code: LIT
• UDI-Device Identifier: 08033477064383
• UDI-Public: 08033477064383
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173515
• 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): 10/16/2019

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: 08/15/2021
• Device Catalogue Number: ADM060300130L
• Device Lot Number: 216031161
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 05/13/2019; 10/15/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 06/26/2019; 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 82