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

Catalog Number S-50-040-120-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 01/31/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.The 5.0x60 supera referenced in b5 is filed under a separate medwatch report number.

Event Description

It was reported that the 5.0x60 supera stent delivery system (sds) was advanced to the target lesion in the superficial femoral artery (sfa) to the proximal popliteal artery.The stent was mostly deployed when there was concern about the guide wire placement.During image review, the sds and partially deployed stent were inadvertently pulled back to the mid sfa where the rest of the stent was deployed in the non-target area.The 5.0x40 supera sds was inserted and advanced to the target lesion, one cm of stent was deployed when it was decided to change out the guide wire.The sds was removed and it was noted that the tip of the sds had separated and remained in the sheath.The guide wire and sheath were removed together, successfully removing the separated tip.A new guide wire was inserted and a new supera sds was successfully deployed to complete the procedure.There was no adverse patient sequela or a clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual inspection was performed on the returned device.The tip separation was confirmed.The deployment issue was not confirmed as it was due to use error.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.The supera instruction for use (ifu) instructs: prior to removal of the delivery system, ensure the supera stent (8) is completely deployed, the thumb slide is retracted, the system lock and deployment lock are locked (in the path of the thumb slide).Based on the reported information, the difficulties were related to use error and there is no indication of a product quality issue with respect 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): 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: 6355117
• MDR Text Key: 68504356
• Report Number: 2024168-2017-01481
• 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: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: S-50-040-120-P6
• Device Lot Number: 5120461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2017
• Initial Date FDA Received: 02/23/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• 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 Age: 68 YR
• Patient Weight: 97