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

Model Number UNK695

Device Problems Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2017

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that stent shortening occurred.The target lesion was located in the severely tortuous, moderately calcified and 100% stenosed superficial femoral artery (sfa).Vascular access was obtained with contralateral approach and a 7x180 innova self-expanding stent was advanced to the sfa and deployed.A mustang balloon catheter was then advanced for post-dilation of the stent, however the balloon catheter failed to cross the lesion and pushed the innova stent causing it to shorten.A 7x40x75 innova stent was then advanced in order to cover the damaged portion of the stent, however it could not cross the lesion.The procedure was completed with dilation using a sterling mr 6.0-150.There were no patient complications reported and the patient's status was stable.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6337071
• MDR Text Key: 67617905
• Report Number: 2134265-2017-01072
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK695
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2017
• 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
• Treatment: GUIDE CATHETER: DESTINATION 6FR 45CM; GUIDE WIRE: RADI FOCUS
• Patient Outcome(s): Required Intervention