MAUDE Adverse Event Report: COOK IRELAND LTD UNKNOWN

Catalog Number UNKNOWN

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

As reported by the initial reporter "device placed in the external iliac and it migrated approx.4cm.They used a stiff.035 wire.The physician did not pre-dilate the lesion, but the physician did post-dilate and gained good wall-apposition.Over the stiff.035 wire, the physician inserted the inner 6fr ansel over the stiff wire - at this point the physician tried to advance the 6fr sheath through the stent (and the sheath and dilator got stuck on the mid-section of the stent).It then dislodged and migrated approx.4 cm's.At this point, the physician backed-up the sheath because she could not get the sheath all the way through.Thus, the physician backed-out the sheath and rotated it and then re-advanced the sheath.At this point the physician was able to get through the stent.She re-ballooned the stent where it landed and then re-ballooned the original segment (where she was trying to treat with the stent).The physician elected to leave the stent where it is currently located.".

Manufacturer Narrative

Common device name: niu stent, superficial femoral artery, drug-eluting (likely).

• Brand Name: UNKNOWN
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 14315334
• MDR Text Key: 291200281
• Report Number: 3005580113-2022-00052
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/06/2022
• Distributor Facility Aware Date: 04/11/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention