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

Model Number H74939293060230

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint device was returned for analysis.Returned product consisted of an innova stent delivery system (sds) with the stent and yellow safety clip detached.The shaft was kinked at the nose cone.The safety lock was received removed from the innova device.The handle was received closed but was opened during analysis for inspection.There was no damage or irregularities to the handle or the components inside the handle, also all the components were accounted for inside the handle.The stent was received deployed and not attached to the innova delivery system.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.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).

Event Description

It was reported that stent inadvertent deployment occurred.A 6 x 20 x 130 innova stent was selected for use.However, the stent deployed outside of the patient even with the safety lock still in place.The procedure was completed with a different device.No patient complications were reported and the patient's status was good.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the 6 x 20 x 130 innova stent was deployed after removal from the packaging and prior to deployment the stent was fully seated by the sheath on the delivery system.

• 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: 5428854
• MDR Text Key: 37986378
• Report Number: 2134265-2016-00488
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: H74939293060230
• Device Catalogue Number: 39293-06023
• Device Lot Number: 0018519679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1