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

Model Number H74939181061530

Device Problems Entrapment of Device (1212); Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2015

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device evaluation by manufacturer: 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).

Event Description

It was reported that the device became stuck on the guidewire.The target lesion was located in the superficial femoral artery.This 6x150x130 innova stent delivery system (sds) and a zipwire guide wire were selected.The zipwire was advanced to the target lesion; however, resistance was felt when advancing the innova sds.An attempt was made to remove the stent but became adhered to the zipwire.The sds and the guide wire were removed together from the patient.It was further reported that the stent had partially deployed.The procedure was completed with another of the same device.No patient complications were reported and the patient's status is stable.

Manufacturer Narrative

Device evaluated by manufacturer: examination of the returned complaint device revealed that the stent was deployed and received detached from the sds.There was blood in the shaft of the device.The outer shaft/sheath was kinked at the nose cone and the inner shaft was kinked 17cm from the tip.The inner diameter (id) of the catheter was measured at the distal tip with a calibrated pin gauge set and met innova specification.A.035¿ amplatz super stiff guidewire was used for functional testing.Functional testing was performed by loading the guidewire into the tip and the handle of the device.The guidewire was able to pass through the shaft with some resistance at the kinks.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 operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that the device became stuck on the guidewire.The target lesion was located in the superficial femoral artery.This 6x150x130 innova stent delivery system (sds) and a zipwire guide wire were selected.The zipwire was advanced to the target lesion; however, resistance was felt when advancing the innova sds.An attempt was made to remove the stent but became adhered to the zipwire.The sds and the guide wire were removed together from the patient.It was further reported that the stent had partially deployed.The procedure was completed with another of the same device.No patient complications were reported and the patient's status is stable.

• 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: 5221151
• MDR Text Key: 31075470
• Report Number: 2134265-2015-07755
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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,Followup
• Report Date: 10/22/2015

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: 07/21/2017
• Device Model Number: H74939181061530
• Device Catalogue Number: 39181-06153
• Device Lot Number: 17141879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2015
• Initial Date FDA Received: 11/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2014
• 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