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

Catalog Number S-55-100-120-P6

Device Problems Detachment Of Device Component (1104); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned and the reported tip separation was confirmed.Based on a visual inspection of the returned device, there is no indication of a product deficiency.A review of the job traveler revealed no non-conformances that would have contributed to the reported event.A query of the electronic complaint handling database and a review of the historical data revealed no other similar incidents reported from this lot.Per the supera instructions for use (ifu) the recommended pre-dilatation diameter for a 5.5 mm stent is greater than 5.5 mm balloon.Precaution: the post-dilated vessel should be at least the size of the stent diameter.If recommended vessel diameter cannot be gained, optimal stent deployment may not be achieved and revised stent sizing should be considered.Based on the reviewed information, no product deficiency was identified.

Event Description

It was reported that the procedure was to treat a lesion in the right common iliac artery and a lesion in the right superficial femoral artery (sfa).An absolute stent was implanted to treat the iliac artery.Pre-dilatation was then performed properly with a 5.0 balloon on the sfa lesion, and a 4.0 x 120 supera stent was implanted distally.The 5.5 x 100 mm supera stent was then deployed in the proximal sfa.It was noted that after the stent was deployed, the thumbwheel was not pulled back and locked.The delivery system was removed without resistance.Angiography was performed and it was observed that the tip of the delivery system had detached and remained in the deployed stent.A guide wire was advanced in an attempt to remove the tip, but this was unsuccessful; therefore, the patient was sent to surgery and the tip was removed.The patient had a good outcome and was clinically stable.No additional information was provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4) failure to follow steps/instructions.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

• 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 462
• Manufacturer (Section G): WEBSTER, TX USA REG#3005325609; abbott vascular; 26531 ynez rd.; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4323742
• MDR Text Key: 12854588
• Report Number: 2024168-2014-08122
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: S-55-100-120-P6
• Device Lot Number: 02265060
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/24/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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
• Treatment: SHEATH: 6F
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 61