MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Model Number S-60-060-120-P6

Device Problems Stretched (1601); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2020

Event Type  malfunction  

Manufacturer Narrative

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 6.0x60 mm supera stent was being deployed in the mid superficial femoral artery (sfa) when the doctor thought it was taking a long time to deploy the stent.At one point, the doctor thought the stent was fully deployed so he retracted the delivery system and noticed that there was still stent remaining to be deployed.This stretched the stent out a little bit, within 10% of its labeled length.After the stent was fully deployed, the doctor thought the deployed length was 150 mm instead of the labeled 60 mm.The extra stent length was deployed in the sfa that the doctor did not intend to treat.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.Visual and dimensional analysis was performed on the returned device.In addition, a review of the provided angiographic images was performed.The reported issue of potential incorrect product labeling was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other complaints reported from this lot.Based on the reported information, review of the provided angiographic images and analysis of the returned supera delivery system, this appears to be related to a potential labeling issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.Na.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10511257
• MDR Text Key: 207392552
• Report Number: 2024168-2020-07499
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211805
• UDI-Public: 08717648211805
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/11/2020

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: 02/28/2022
• Device Model Number: S-60-060-120-P6
• Device Catalogue Number: S-60-060-120-P6
• Device Lot Number: 0031061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 11/02/2020
• Supplement Dates FDA Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 71