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

Catalog Number SE-05-200-120-6F

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 10/10/2018

Event Type  malfunction  

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 during device unpackaging and prior to use in the procedure the supera stent delivery system (sds) distal tip was noted to be detached/missing.The device was not used; there was no patient interaction.A different device was used in the procedure without reported issue.No additional information was provided.

Manufacturer Narrative

Internal file number: (b)(4).Evaluation summary: visual and functional inspections were performed on the returned device and the reported tip detachment was confirmed.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 reported for this lot.The investigation was unable to determine the cause for the reported tip detachment.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
• MDR Report Key: 8026321
• MDR Text Key: 125757932
• Report Number: 2024168-2018-08329
• 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,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/07/2019

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: 12/31/2018
• Device Catalogue Number: SE-05-200-120-6F
• Device Lot Number: 7011661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Initial Date Manufacturer Received: 10/15/2018
• Initial Date FDA Received: 10/31/2018
• Supplement Dates Manufacturer Received: 02/02/2019
• Supplement Dates FDA Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1