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

Catalog Number SE-05-080-120-6F

Device Problem Inaccurate Delivery (2339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2015

Event Type  malfunction  

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 relevant information.

Event Description

It was reported that the procedure was to treat a chronic totally occluded de novo lesion with moderate calcification in the distal superficial femoral artery.Pre-dilatation was performed with a 6 mm balloon and the introducer sheath was approximately 20 cm to the proximal end of the stent.During deployment, the deployment lock unlocked and the thumb slide advanced to the most distal position on the handle; however, the supera stent distally missed covering 25% of the lesion.The proximal end of the stent was deployed in healthy tissue.Under fluoroscopy, the delivery system was removed and another supera stent was used to cover the lesion completely.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned and the reported inaccurate delivery could not be replicated as the stent had already been deployed.Based on a visual inspection of the returned product, there is no indication of a product quality issue with respect to manufacture, design or labeling.The investigation determined that a conclusive cause for the reported difficulty could not be determined.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.Based on the information reviewed, there is no indication the issue was caused by, or related to the design, manufacture or labeling.

• 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: 5320719
• MDR Text Key: 34789106
• Report Number: 2024168-2015-07904
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: SE-05-080-120-6F
• Device Lot Number: 5012661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2015
• Initial Date FDA Received: 12/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• 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