MAUDE Adverse Event Report: AV-TEMECULA-CT SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant products: sheath: 45 cm long introducer sheath; stent: two other supera stents in mid and distal left sfa.It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.The investigation concluded that this event appears to be due case circumstances.A review of the lot history record for this product and complaint handling data could not be performed because the part and lot numbers were not provided.Based on the information reviewed, there is no indication the issue was caused by or related to the design, manufacture or labeling of the device.

Event Description

It was reported that approximately three months after the 4.5x120 supera stent was implanted in the left proximal superficial femoral artery (sfa), the patient was treated for the right sfa percutaneously through the left groin access site.The 45 cm long introducer sheath was inserted and caught on the supera stent and inadvertently moved it to the right sfa.The patient was moved from the outpatient catheterization lab facility to the hospital operating room where the surgeon performed a cutdown to remove the proximal sfa stent.The surgeon then percutaneously treated the right sfa with atherectomy and placement of three supera stents.The patient tolerated the surgery.No additional information was provided.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5481668
• MDR Text Key: 39740446
• Report Number: 2024168-2016-01371
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Weight: 50