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

Catalog Number SE-06-060-120-6F

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problems Intimal Dissection (1333); Occlusion (1984)

Event Date 09/03/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 a lesion with mild calcification in the popliteal artery.The sheath was located in the right common iliac.Pre-dilatation was performed with a 7.0 mm balloon at 8 atmospheres for 120 seconds.A 6 x 60 mm supera was prepared in accordance with the instruction for use (ifu) and advanced to the lesion without issues.The first system lock was released and the stent released without problems.The second lock was disengaged and released the stent.Both locks were engaged again.Under fluoroscopy, it was confirmed that the stent was fully released from the sheath.There was no waist noted to the deployed stent or proximal end of the lesion.The stent was successfully implanted with very good results.The sheath was locked and the physician started to retract the delivery system, but during the attempt to remove the device from the 6fr sheath, resistance was felt when the sheath reached the introducer sheath which was located in the common iliac.Gentle force was applied and the delivery system slipped out of the sheath.When the device outside the patient anatomy, the catheter tip was noted to be missing and was found in the femoral artery.A guide wire and balloon were used to catch the separated tip and remove it from the anatomy.However, during removal of the tip a dissection and occlusion occurred in the tibiofibular trunk.Recanalization was performed and a xience stent was implanted to treat the vessel.The patient is doing fine.There was no adverse patient sequela.No additional information was available.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned and the reported tip separation was confirmed.The reported difficult to remove could not be confirmed as the difficulties were based on case circumstances.Investigation determined that the reported tip separation, difficulty removing, removal of foreign body, and additional non-surgical treatment appear to be due to operational context of the procedure.A conclusive cause for the dissection and occlusion could not be determined.A review of the job traveler revealed no non-conformances for this lot.The results of the historical data review for this lot revealed no other similar incidents reported 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.The reported patient effects of dissection and occlusion are known potential patient effect as listed in the supera instructions for use (ifu).A conclusive cause for the dissection and occlusion could not be determined; however, there is no indication to suggest that the issue was caused by, or related 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): WEBSTER, TX USA REG#3005325609; abbott vascular; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5105605
• MDR Text Key: 26824880
• Report Number: 2024168-2015-05647
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Followup
• Report Date: 10/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Catalogue Number: SE-06-060-120-6F
• Device Lot Number: 02331066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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