MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE INNOVA¿; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number H74939180061570

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that partial deployment occurred.A 6x150x75 innova¿ stent was selected for a procedure.During the procedure, there was incomplete deployment of the stent with the appropriated thumbwheel.The deployment was performed manually.There were no patient complications reported.

Manufacturer Narrative

Updated: device evaluated by mfr., eval summary attached, method codes, results codes, conclusion codes.Device evaluated by mfr: returned product consisted of an innova self-expanding stent delivery system (sds).The outer shaft and the remainder of the device were checked for damage.Visual examination showed a kink at the nosecone.No damage was noticed on the mid-shaft.The stent was not inside the device when returned.The handle was opened to inspect for additional damage.No damage was noticed inside of the handle.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

Event Description

It was reported that partial deployment occurred.A 6x150x75 innova¿ stent was selected for a procedure.During the procedure, there was incomplete deployment of the stent with the appropriated thumbwheel.The deployment was performed manually.There were no patient complications reported.

• Brand Name: INNOVA¿
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 7265450
• MDR Text Key: 100010417
• Report Number: 2134265-2018-00667
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: H74939180061570
• Device Catalogue Number: 39180-06157
• Device Lot Number: 20279924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Date Manufacturer Received: 02/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1