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

Model Number	S-60-100-120-P6
Medical Device Problem Codes	Material Separation (1562); Material Deformation (2976)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported tip detachment was confirmed.The material deformation (waist) to the stent could not be confirmed as the stent remains implanted in the patient.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 revealed no other complaints.The investigation was unable to determine a cause for the reported difficulties.It may be possible that the tip detachment was the result of the tip being trapped in the narrowed portion of the stent and during retraction of the thumbslide, the tip detached.The reported waist in the stent may be the result of anatomical conditions as the lesion site was described as 90% stenosed.However, this could not be confirmed and a definitive cause for the difficulties could not be determined.The foreign body in patient was related to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat the right superficial femoral artery with no tortuosity or calcification but with 90% stenosis.The vessel was 6 mm and was prepared with laser atherectomy and a 6x100 mm balloon for 2 minutes.The sheath was 6fr 90 cm.The 6.0x100 mm supera self expanding stent (ses) was deployed without issue.There was waist noted at the mid body of the stent.Reportedly, the physician rotate the system lock and the deployment lock into the locked position.Then, the tip of the delivery system separated and embolized into the patient's peroneal artery where it remains as it is not able to be retrieved.No retrieval attempt was made.No resistance was noted during advancement or removal.The patient does not have limb threatening ischemia.No additional information was provided.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Common Device Name: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10473261
• Report Number: 2024168-2020-07233
• Device Sequence Number: 2344103
• Product Code: NIP
• UDI-Device Identifier: 08717648211829
• UDI-Public: 08717648211829
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: S-60-100-120-P6
• Device Catalogue Number: S-60-100-120-P6
• Device Lot Number: 9102161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 08/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6F 90 CM SHEATH
• Outcome Attributed to Adverse Event: Other
• Patient Age: 86 YR
• Patient Weight: 59