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

Catalog Number 42065040-120

Device Problems Difficult to Remove (1528); Material Separation (1562)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 02/07/2019

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 relevant information.

Event Description

It was reported that the procedure was to treat a radial fistula stenosis.The reference vessel diameter was 7.0 mm and atherectomy was not used.The vessel was prepared with a 6.0mm balloon and an 11cm 6fr sheath was used.The supera self expanding stent (ses) was being used to reline a non-abbott ses that was fractured.It was confirmed under fluoroscopy that the supera ses had emerged from the sheath and was fully released.During removal, the tip of the supera ses separated inside the patient after getting caught on the previously implanted non-abbott ses.The tip was not retrieved but jailed with another unspecified stent.There were no adverse patient sequela and there was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number: (b)(4).Evaluation summary: visual and dimensional inspections were performed on the returned device.The tip detachment was confirmed.The difficulty removing was not confirmed as it was related to case circumstances.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 difficulty removing, and tip detachment were likely attributed to case circumstances and user related.It is likely that failing to retract the tip and lock the system lock contribute to the tip getting caught on the previously implanted non-abbott stent resulting in difficulty removing and the tip detachment.There is no indication of a product quality issue with respect to the design, manufacture, or labeling.

• 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
• MDR Report Key: 8380199
• MDR Text Key: 137503915
• Report Number: 2024168-2019-01592
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2019

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: 07/31/2020
• Device Catalogue Number: 42065040-120
• Device Lot Number: 8080262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Initial Date Manufacturer Received: 02/07/2019
• Initial Date FDA Received: 02/28/2019
• Supplement Dates Manufacturer Received: 03/13/2019
• Supplement Dates FDA Received: 03/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention