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

Catalog Number 42055200-120

Device Problems Entrapment of Device (1212); Stretched (1601); Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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.

Event Description

It was reported that the procedure was performed to treat an occluded, mildly tortuous, heavily to moderately calcified lesion in the proximal to distal right superficial femoral artery (sfa).Angioplasty was performed with an unspecified device.A 5.5x200mm supera self-expanding stent system (sess) was advanced without reported issue; however, the thumb slide was difficult [to move] and became stuck during deployment of the last 2 cm of the stent.The sess then pulled to attempt to release the system, but instead the proximal portion of the stent became elongated.The case was abandoned and the patient went to surgery.Part of the sess white tip remained stuck in the proximal 2 cm of the stent; therefore, a femoral cutdown was performed to cut the stent near the ostium at the top of the sfa.The entire delivery system, including the white tip, was completely removed from the patient anatomy.Part of the stent was cut down and was removed from the patient, and the remaining part of the stent remained in the target lesion.The patient remained stable.No additional information was provided.

Manufacturer Narrative

(b)(4).Visual inspections were performed on the returned device.The resistance, deployment issues and stent elongation were not confirmed as the stent had already been deployed.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 investigation determined that the reported difficulties were likely due to case circumstances.It may be possible that the distal sheath of the delivery system was entrapped or bent within the anatomy preventing the ratchet from engaging the stent properly to fully release the stent and while attempting to pull the delivery system back to release the stent, the stent began to elongate.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: 8687443
• MDR Text Key: 147610264
• Report Number: 2024168-2019-04577
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 42055200-120
• Device Lot Number: 8071661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2018
• 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