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); Difficult or Delayed Positioning (1157); Difficult to Remove (1528)

Patient Problem Intimal Dissection (1333)

Event Date 12/17/2014

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a moderately calcified lesion in the left superficial femoral artery (sfa).Pre-dilatation was performed using a 6.0mm unspecified balloon dilatation catheter (bdc).The 5.5mmx100mmx120cm supera self-expanding stent system (sess) was successfully advanced to the target lesion.There was no issue with the handle or locks and the deployment lock was opened; however, during deployment the proximal portion of the stent could not be fully deployed and deployed in the sheath.While attempting to remove the delivery catheter, the tip caught on the partially deployed stent and separated.A cut-down was performed to explant the stent and retrieve the separated tip.A vessel dissection was noted.A 6.0mmx200mmx120cm non-abbott sess was deployed to treat the dissection and the target lesion.There was no reported adverse patient sequela; however, there was a reported clinically significant delay in the procedure due to the surgical intervention.Additionally, the patient was kept hospitalized for observation due to the surgical intervention.There was no additional information provided.

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis and the difficulties deploying the stent could not be tested due to the stent being fully deployed.The difficult to remove could not be tested as it was based on case circumstances.The tip separation was confirmed.Based on a visual inspection, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances.A query of the electronic complaint handling database revealed no other similar incidents reported from this lot.Based on the reviewed information, no product deficiency was identified.

• 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: 4403055
• MDR Text Key: 5126902
• Report Number: 2024168-2015-00166
• 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: 12/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: S-55-100-120-P6
• Device Lot Number: 02333050
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/05/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2015
• Initial Date FDA Received: 01/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/22/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 95