MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ESPRIT¿; STENT, INFRAPOPLITEAL, ABSORBABLE

Model Number	1203250-28
Medical Device Problem Codes	Break (1069); Material Too Rigid or Stiff (1544); Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the peroneal artery with moderate calcification and mild tortuosity.A 6fr x 45 cm sheath and a 0.014¿ non-abbott guidewire was used in the case.The physician accessed the anatomy through the right groin and went up and over the iliac arch to the left side.Ivus (intravascular ultrasound) was used to visualize the superficial femoral artery (sfa) and a drug coated balloon (dcb) was advanced to the sfa.Another ivus run was completed after the inflation of the dcb and everything looked good.The target lesion was in the peroneal artery and was pre-dilated with a balloon dilatation catheter.The esprit btk everolimus eluting bioresorbable scaffold system was prepped and inserted.The physician commented that the device felt stiff and there was some resistance experienced when advancing.The device was advanced up and over the iliac arch, but once on the other side, there was resistance and the delivery system was pushing the sheath back towards the aorta.The sds would not go over the iliac artery.After multiple attempts, the sds was removed from the patient without any issue.The procedure was ended.When the sds was removed from the body, a kink at the guidewire exit notch was observed.Device analysis of the returned device found that the bayonet/support wire was separated 1.5cm distal to the outer member to hypotube bond but held together by the shaft.The outer member was torn at the same location of the separated bayonet/ support wire.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported deformation due to compressive stress was confirmed through a support wire break and outer member damage.The reported failure to advance, difficulty to advance and material too rigid or stiff could not be replicated in a testing environment as it was related to operational context of the procedure.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.The reported stiffness of the device is a personal opinion/preference of the physician and not a quality issue with respect to manufacture, design or labeling.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: ESPRIT¿
• Common Device Name: STENT, INFRAPOPLITEAL, ABSORBABLE
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 19886947
• Report Number: 2024168-2024-09110
• Device Sequence Number: 17918270
• Product Code: NXW
• UDI-Device Identifier: 08717648357237
• UDI-Public: (01)08717648357237(17)250403(10)4040461
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P230036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/03/2025
• Device Model Number: 1203250-28
• Device Catalogue Number: 1203250-28
• Device Lot Number: 4040461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/10/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 08/01/2024
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: 0.014¿ GLIDEWIRE ADVANTAGE.; SHEATH: 6F, 45 CM DESTINATION (TERUMO).
• Patient Sex: Unknown