MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number	1804300-18
Medical Device Problem Codes	Material Rupture (1546); Difficult to Advance (2920); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.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 handling database identified no similar complaints from this lot.A conclusive cause for the reported difficulties could not be determined; however, factors that could contribute to difficult to advance/position include, but are not limited to, patient anatomical morphology, patient disease state, pre-dilatation strategy, device placement technique, interaction with previously placed stents or accessory devices.Factors that may contribute to material ruptures include, but are not limited to, material damage, materials, inflation technique, interactions with other devices, lesion calcification and tortuosity or insufficient preparation prior to use.Factors that may contribute to an activation failure including expansion failures (inflation issues) include, but are not limited to, inflation technique, contrast concentration, loose connection with the indeflator, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.In this case, it is possible that the device may have interacted with the heavily calcified, moderately tortuous, 90% stenosed lesion during advancement, as resistance was noted, causing the reported difficult to advance/position.Further interaction with the challenging anatomy may have caused the reported material rupture, ultimately contributing the reported activation failure including expansion failures; however, without the device to examine, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the mid left anterior descending (lad) coronary artery with heavy calcification, moderate tortuosity and 90% stenosis.Pre-dilation was performed several times with a 2.5x15 non-abbott balloon dilatation catheter (bdc).The 3.0x18mm xience skypoint stent delivery system (sds) was advanced to the lesion with resistance noted with vessel calcification.Pressure was applied once when the balloon ruptured at 6 atmospheres and the stent did not deploy and remained mounted on the sds.The sds was suspected of having a pinhole from the vessel calcification.The sds was withdrawn intact.Additional dilatation was performed with the non-abbott balloon several times, then a 2.75x18mm xience skypoint stent was implanted without issue to complete the procedure.Post dilation was performed with a non-abbott bdc.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 19361719
• Report Number: 2024168-2024-06178
• Device Sequence Number: 6342976
• Product Code: NIQ
• UDI-Device Identifier: 08717648233241
• UDI-Public: (01)08717648233241(17)261204(10)3120741
• 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
• Report Date (Section B): 05/21/2024

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 Catalogue Number: 1804300-18
• Device Lot Number: 3120741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2023
• 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