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

Model Number UNK695

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vasoconstriction (2126)

Event Date 01/13/2016

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr.: the device was not received for analysis.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Event Description

Same case as: mdr id: 2134265-2016-01479.(b)(6).It was reported that vessel spasm occurred.In (b)(6) 2014, the patient presented as an outpatient and was treated with antiplatelet therapy or given a dose prior to the index procedure.The target lesion was located in the left mid (superficial femoral artery (sfa) with 90% stenosis, was 50 mm long and a reference vessel diameter of 5.5 mm, and was classified as a tasc ii a lesion.The target lesion was treated with pre-dilatation and placement of a drug eluting stent (des) sfa stent.Following post-dilatation, residual stenosis was 0%.A previously implanted innova self-expanding stent was found to have 90% in-stent restenosis (isr).Percutaneous transluminal angioplasty (pta) was performed to treat the isr of the innova self-expanding stent.In (b)(6) 2016, a de novo stenosis was stented in the left proximal sfa.Subsequently, a 6 x 60 innova self-expanding stent was dilated and when the sheath was removed, a spasm of the sfa was observed and was subsequently dilated.

• Brand Name: INNOVA SELF-EXPANDING STENT SYSTEM
• 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: 5489258
• MDR Text Key: 39977353
• Report Number: 2134265-2016-01478
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: SIMILAR
• 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
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK695
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention
• Patient Age: 51 YR