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

Device Problems Stretched (1601); Device Damaged by Another Device (2915); Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The udi is unknown because the part number and lot number were not provided.Date of implant has been estimated.The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed and a similar incident query could not be performed because the product was not returned for evaluation and the part and lot numbers were not reported.The investigation determined the reported difficulties were due to operational context.The reported difficulties occurred due to the suture of the proglide device inadvertently capturing the previously implanted supera stent.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that an arteriotomy closure of the mildly calcified left common femoral artery was attempted using a proglide device with a 6f sheath after an interventional iliac stenting procedure.Reportedly, the suture of the proglide device captured a previously implanted supera stent.When the suture was pulled, the supera stent moved into the tissue tract.The proglide device and suture were removed.The patient was taken to surgery and a cutdown was performed and the extravascular portion of the stent was removed.Hemostasis was achieved by surgical suturing.A blood transfusion was given.There was a clinically significant delay in the procedure or therapy.Hospitalization was extended.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: 7926323
• MDR Text Key: 122340212
• Report Number: 2024168-2018-07575
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• 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: 09/11/2018
• 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: VESSEL CLOSURE: PROGLIDE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 103