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

Catalog Number S-65-150-120-P6

Device Problems Detachment Of Device Component (1104); Difficult or Delayed Positioning (1157); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2014

Event Type  Injury  

Event Description

It was reported that the 6.5mm, superficial femoral artery (sfa), mildly calcified lesion was pre-dilated with a 6.0 armada dilatation catheter.During supera stent deployment, under fluoroscopy, the stent did not release from the delivery catheter.The introducer sheath was touching the proximal end of the stent.The physician did not see the proximal end of the stent exit, the outer sheath and the stent began deploying inside the procedural sheath.The sheath was pulled back and the stent deployed on the sfa lesion.Following, the device tip detached, remaining on the guidewire.A balloon catheter was able to pin the tip to the delivery catheter.Both were removed as a single unit.The stent remained implanted on the lesion and good results were noted.There was no stent elongation.There were no adverse patient effects and there was no clinically significant delay.There was no additional information 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 instructions.The stent was deployed although the physician did not see the proximal end of the stent exit the outer sheath.The device was retained by the hospital.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

(b)(4).It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of the job traveler revealed no non-conformances that would have contributed to the reported event.The results of the historical data review for this lot did not indicate a manufacturing issue.A query of the complaint handling database revealed no other similar incidents reported from this lot.Per the supera instructions for use (ifu), the recommended pre-dilatation diameter for a 6.5 mm stent is greater than 6.5 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.

• 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: 4306167
• MDR Text Key: 5190673
• Report Number: 2024168-2014-08015
• 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: 11/13/2014

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: 02/29/2016
• Device Catalogue Number: S-65-150-120-P6
• Device Lot Number: 02274070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2015
• Initial Date FDA Received: 12/08/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• 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
• Patient Age: 73 YR