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

Model Number H74939181088030

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that partial deployment of a stent occurred.The target lesion was located in the superficial femoral artery (sfa).During preparation the surgeon noticed the 8x80x130 innova bare metal stent was partially deployed.The procedure was completed with a different device.No patient complications were reported.This product is only ous approved but it is similar to an approved u.S.Device.

Event Description

It was reported that partial deployment of a stent occurred.The target lesion was located in the superficial femoral artery (sfa).During preparation the surgeon noticed the 8x80x130 innova bare metal stent was partially deployed.The procedure was completed with a different device.No patient complications were reported.This product is only ous approved but it is similar to an approved us device.

Manufacturer Narrative

Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Manufacturer Narrative

Updated: device avail.For eval; returned to mfr.On; device returned to mfr; evaluated by mfr; eval summary attached; method codes; result codes; conclusion codes device evaluated by mfr: examination of the returned device revealed the safety-lock was securely attached to the thumb-wheel, as-received; however, it could not be determined if it was removed and replaced prior to return.There was a kink with shaft damage at the handle.The stent was partially expanded with a length of 7.5mm.There was no evidence of any material or manufacturing deficiencies contributing to the confirmed premature deployement.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

• Brand Name: INNOVA?
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4321232
• MDR Text Key: 5241162
• Report Number: 2134265-2014-07777
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/26/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2017
• Device Model Number: H74939181088030
• Device Catalogue Number: 39181-08803
• Device Lot Number: 17111058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2015
• Initial Date FDA Received: 12/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2014
• 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