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

Catalog Number SE-06-080-120-6F

Device Problems Detachment Of Device Component (1104); Positioning Failure (1158); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2015

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 investigation.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 to treat a lesion with mild tortuosity and mild calcification in the proximal femoral artery.Pre-dilatation was performed with a 6 x 60 mm armada balloon to 16 atmospheres for 6 seconds.A 6 x 120 mm supera stent was implanted successfully.Then, an attempt was made to overlap with a 6 x 80 mm supera stent; however, there was moderate resistance during advancing with the anatomy and at the time of the stent release, the catheter tip separated preventing further stent deployment.The stent had partially deployed and the system was locked.Under fluoroscopy, the device was withdrawn from the anatomy and replaced with another device.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Type of reportable event changed to serious injury.Evaluation summary: the device was returned and the reported deployment difficulty and resistance could not be confirmed as the stent had already been deployed.The tip detachment was confirmed.A conclusive cause for the deployment issue could not be determined.The resistance advancing, difficulty removing and tip detachment appears to be due to operational context.The cause for the reported dissection and the relationship to the product, if any, cannot be determined; however, dissection is a known potential patient effect as listed in the supera instructions for use.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.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 of the device.(b)(4).

Event Description

Additional information received: there was resistance during removal of the supera from the patient's anatomy.Also, a dissection occurred at the end of the procedure which was treated with a drug eluting stent.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: 5156415
• MDR Text Key: 28740149
• Report Number: 2024168-2015-06119
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 11/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: SE-06-080-120-6F
• Device Lot Number: 5042461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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: 74 YR