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

Catalog Number SE-05-150-120-6F

Device Problem Positioning Failure (1158)

Patient Problem Hematoma (1884)

Event Date 01/24/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a lesion in the superficial femoral artery with moderate calcification.The lesion was pre-dilated with a 6 mm balloon.The 5 x 150 mm supera veritas self-expanding stent system (sess) was advanced to the lesion.The stent deployment was performed, but the stent was stuck in the sess and would not release from the system.The system sheath could not be retracted; therefore, the device and the stent were retracted to the femoral site.The introducer sheath was removed and the artery was re-catheterized.A guide catheter was then used to remove the stent from the femoral artery.After removal, the stent released from sess.Due to the removal procedure, the patient had parietal and retroperitoneal hematoma requiring a transfusion (2 globular concentrates), which was considered a clinically significant delay in the procedure.Another stent was used to treat the lesion.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was returned and visual inspections were performed.The inner member including the tip was separated.The inner member material at the separation was jagged.The deployment difficulty was unable to be confirmed as only the tip and a portion of the inner member and stent were returned.It may be possible that the shaft was bent or entrapped within the anatomy such that the ratchet efficiency was compromised and unable to fully deploy the stent properly; however, this could not be confirmed.The investigation was unable to determine a conclusive cause for the reported deployment issue and patient effect of hematoma.Hematoma is listed as an adverse patient effect associated with the use of the device and is listed in the supera instruction for use.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 6330040
• MDR Text Key: 67398410
• Report Number: 2024168-2017-01180
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: SE-05-150-120-6F
• Device Lot Number: 6111661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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