MAUDE Adverse Event Report: ABBOTT VASCULAR INC. XIENCE SKYPOINT; CORONARY DRUG-ELUTING STENT

Model Number	1804250-18
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Difficult to Advance (2920); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
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 to treat the mid left anterior descending (lad) coronary artery with heavy calcification, mild tortuosity and 90% stenosis.A guide wire was delivered and two non-abbott balloons were used for pre-dilatation.Then, the 2.5x18 mm xience skypoint stent delivery system (sds) was advanced to the lesion with resistance noted with the lesion and deployment was attempted.The device was inflated once to 2 atmospheres and it was noted that the balloon was ruptured.The sds was attempted to be removed but there was resistance with the anatomy.A pinhole rupture was noted.A guide catheter which was already present inside the anatomy was advanced to mount the stent and then the sds was pulled strongly and the device was removed together with the guiding catheter.Two non-abbott stents were deployed to complete the procedure.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.Upon removal from the anatomy the sds was inspected and a pinhole rupture was noted.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported material rupture and activation failure were confirmed.The reported difficulty to advance and difficulty to remove could not be replicated in a testing environment as they were both related to operational context of the procedure.Scanning election microscopy (sem) was performed.The reviewer concluded the balloon failure may be attributed to mechanical damage to the outer surface.The leak was located in the distal working length along a stent impression.Lot history record (lhr) was performed and revealed no indication of a product quality issue.Corrective and preventive actions (capa) reviews were performed and revealed a possible product quality issue.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation determined the reported difficulty to advance, activation failure and difficulty to remove appear to be related to circumstances of the procedure.The investigation determined a potential product quality issue based on the reported material rupture complaint and the confirmed balloon pinhole.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.Additional information: d4 - model # added corrections: d1 - brand name updated d2a - common device name updated d3 - name updated d3 - address, city, postal code updated.

• Brand Name: XIENCE SKYPOINT
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18915415
• Report Number: 2024168-2024-03377
• Device Sequence Number: 6827017
• Product Code: NIQ
• UDI-Device Identifier: 08717648233081
• UDI-Public: (01)08717648233081(17)260813(10)3082141
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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: 08/13/2026
• Device Model Number: 1804250-18
• Device Catalogue Number: 1804250-18
• Device Lot Number: 3082141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/27/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2023
• 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
• Patient Sex: Unknown