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

Model Number	1804300-33
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135)
Date of Event	03/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional device referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was performed to treat a de novo lesion in the heavily calcified, non-tortuous, 90% stenosed left anterior descending coronary artery.After optical coherence tomography (oct) was performed, a non-abbott atherectomy system was used.The oct had an unspecified error and was replaced with an unspecified intravascular ultrasound catheter.A non-abbott balloon was used for pre-dilatation with a non-abbott guide wire.A 3x33mm xience skypoint stent delivery system (sds) was advanced, and the stent was implanted.However, the proximal portion of the stent was not expanded enough, so a non-compliant non-abbott balloon was used for post-dilatation.The patient's blood pressure decreased, and a perforation was noted.An unspecified graftmaster covered stent was implanted, but there was bleeding somewhere else in the patient.Heart massage was used as treatment as well, but the patient expired on (b)(6) 2021.No additional information was provided.
Event or Problem Description
It was reported that the procedure was performed to treat a de novo lesion in the heavily calcified, non-tortuous, 90% stenosed left anterior descending coronary artery.After optical coherence tomography (oct) was performed, a non-abbott atherectomy system was used.The oct had an unspecified error and was replaced with an unspecified intravascular ultrasound catheter.A non-abbott balloon was used for pre-dilatation with a non-abbott guide wire.A 3x33mm xience skypoint stent delivery system (sds) was advanced, and the stent was implanted.However, the proximal portion of the stent was not expanded enough, so a non-compliant non-abbott balloon was used for post-dilatation.The patient's blood pressure decreased, and a perforation was noted.An unspecified graftmaster covered stent was implanted, but there was bleeding somewhere else in the patient.Heart massage was used as treatment as well, but the patient expired on (b)(6) 2021.Subsequent to the initially filed report, the following information was received: the patient presented with angina.The 3x33mm xience skypoint stent did not have any deployment issues, and the non-compliant non-abbott balloon was used for standard post-dilatation.The perforation was noted in the deployed xience skypoint stent.In the opinion of the physician, the use of this 3x33mm xience skypoint stent did not possibly cause or contribute to the death in any way.No issues were noted with the 3.5x19mm graftmaster covered stent, which sealed the perforation.In the opinion of the physician, the use of this graftmaster did not possibly cause or contribute to the death in any way.It is unknown whether an autopsy was performed; therefore, thrombosis in the graftmaster was unable to be confirmed.A blood transfusion was performed as well.There was bleeding noted in another location; this bleeding led to cardiac tamponade, which led to the patient death.A heart lung machine was unable to be used since both of the patient¿s legs had total occlusion and there was no route for a cannula to be inserted to which the physician considers to be an indirect cause of the death.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A medical review was performed by an abbott vascular clinical specialist.The reviewer concluded while it was initially thought that the most likely cause of the perforation was due to the usage of the rotational atherectomy device, as this is a known cause of 1.2% of coronary artery perforations, without the cine images to review and additional information requests answered fully, it cannot be stated definitely that the rotational atherectomy was not the cause of the perforation.Based on the recent information, there was no perforation image observed just after the xience skypoint was implanted, and then, after confirming the lumen with ivus and conducting additional dilatation, the decrease of blood pressure and the perforation were noted.The reported patient effects of perforation and hypotension are listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The xience skypoint device is not currently commercially sold in the us; however, it is similar to a device sold in the us.B1: product problem removed b2: outcomes attributed to ae changed from death to required intervention h6: codes 1802, 1888, and 2682 were removed.

• 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
• MDR Report Key: 11656748
• Report Number: 2024168-2021-03061
• Device Sequence Number: 19735422
• Product Code: NIQ
• UDI-Device Identifier: 08717648233272
• UDI-Public: 08717648233272
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2021

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: 09/22/2023
• Device Model Number: 1804300-33
• Device Catalogue Number: 1804300-33
• Device Lot Number: 0091741
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 06/21/2021
• 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: NC SAPPHIRE BALLOON; SION BLUE GUIDE WIRE; NC SAPPHIRE BALLOON; SION BLUE GUIDE WIRE
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 40