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

Model Number H74939181062030

Device Problems Fracture (1260); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2014

Event Type  Injury  

Event Description

It was reported that during a stenting treatment procedure a tip detachment occurred.The 100% stenosed target lesion was located in the mildly calcified superficial femoral artery (sfa).The physician selected a 6x200x130 innova¿ self expanding stent and advanced it to the lesion.The stent was deployed successfully.During removal of the delivery system through the unspecified introducer sheath resistance was encountered.The tip of the delivery device broke off and was retrieved using a vascular snare.No additional patient complications were reported and the patient's status is stable.This product is only ous approved but it is similar to an approved us device.

Manufacturer Narrative

Patient age at time of event: 18 years or older.(b)(4).Device evaluated 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).

Manufacturer Narrative

Device evaluated by manufacturer: a visual examination identified the inner shaft was separated 28cm from the middle shaft.The separated end were stretched and jagged, which suggests that the separation may be related to tensile overload.There was no evidence of any material or manufacturing deficiencies contributing to the separation.The distal separated portion of the device, which includes the distal tip was not returned.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 during a stenting treatment procedure a tip detachment occurred.The 100% stenosed target lesion was located in the mildly calcified superficial femoral artery (sfa).The physician selected a 6x200x130 innova self expanding stent and advanced it to the lesion.The stent was deployed successfully.During removal of the delivery system through the unspecified introducer sheath resistance was encountered.The tip of the delivery device broke off and was retrieved using a vascular snare.No additional patient complications were reported and the patient's status is stable.This product is only (b)(6) approved but it is similar to an approved us device.

• 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: 4127120
• MDR Text Key: 4795986
• Report Number: 2134265-2014-06024
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 09/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2016
• Device Model Number: H74939181062030
• Device Catalogue Number: 39181-06203
• Device Lot Number: 16597978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2013
• 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