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

Catalog Number S-60-150-120-P6

Device Problems Positioning Failure (1158); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned for analysis.The investigation was unable to determine a conclusive cause for the reported deployment difficulty and kinked tip.The surgical procedure was related to circumstances of the procedure.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history did not indicate a lot specific quality issue.Based on the information reviewed, 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 during a procedure to treat a lesion in the extremely calcified superficial femoral artery, a 6 fr non-abbott stent was placed.Pre-dilatation was performed with a non-abbott balloon catheter at nominal pressure.A 6x150 supera peripheral stent system was advanced and during stent deployment, the tip was not advancing when the thumb slide was advanced.The tip somehow bent and could not come through the sheath.The tip was caught in the partially deployed stent and then was eventually stuck in the sheath.Reportedly, the supera sheath tip was cut off and removed via cut down surgery with the sheath.The delivery system came out through the 6fr non-abbott sheath.The stent was never fully deployed or placed and does not remain in the patient anatomy.The patient was fine; however, there was a clinically significant delay in the procedure due to the need to perform a cut down.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.The investigation was unable to determine a conclusive cause for the reported deployment difficulty and kinked tip.The difficulty removing and surgical procedure was related to circumstances of the procedure.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history did not indicate a lot specific quality issue.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the previously filed reported, user facility medwatch was received: during balloon angioplasty of left popliteal artery, stent could not be retracted through sheath requiring surgical intervention to remove.During surgical removal, stent was removed in its entirety, but sheath could not be removed.A stif wire was then placed through the sheath splaying the bifurcation enough to allow removal of the sheath in its entirety.

• 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: 5726047
• MDR Text Key: 47426633
• Report Number: 2024168-2016-03901
• 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,Followup
• Report Date: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: S-60-150-120-P6
• Device Lot Number: 5082161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2015
• 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
• Patient Age: 95 YR
• Patient Weight: 76