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

Model Number	1804400-38
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Pericardial Effusion (3271)
Date of Event	07/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat the right coronary artery with occlusion and 3 areas of high grade stenosis.A balance middleweight (bmw) guide wire was used to cross the lesions in the right coronary artery and into the posterolateral branch.A 4.0x38 mm xience skypoint stent was positioned over the first 2 stenoses and deployed at 18 atmospheres (atm).There was waist seen in the middle of the stent and angiogram post stent deployment showed a perforation at the distal edge of the stent.The stent balloon was advanced and inflated to 4 atm for about 5 minutes.The leak was decreased but still present so another inflation was performed for 5 minutes.The bmw guide wire was then moved in a parallel fashion to the vein graft.At this time there was minimal extravasation of dye at the perforation site so the distal portion of the lesion was treated with a 3.5x18 mm xience skypoint stent deployed at 12 atm.Post dilatation was performed with a 4.0x12 mm balloon and the balloon was then used for the perforation site for 8 minutes.Angiogram following this showed extravasation of contrast and transthoracic echocardiogram (tte) showed persistent pericardial effusion.The 4.0x19 mm graftmaster covered stent was positioned covering the distal edge of the first stent and spaced evenly on either side and deployed at 17 atm.There was another site of perforation so a 4.0x26 mm graftmaster covered stent was implanted at 15 atm overlapping largely with the first graftmaster and extending more proximally.Angiograms showed no extravasation of contrast.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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 identified no other incidents from this lot.It is possible that the clamp seal was not entirely closed; thus resulting in the reported leak; however as the device was not returned for analysis this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.The treatment appears to be related to the operational context of the procedure as the y-connector had to be held throughout the procedure in order to stop the leakage.There is no indication of a product quality issue with respect to manufacture, design or labeling.The graftmaster referenced is being filed under a separate medwatch report number.
Additional Manufacturer Narrative
H10: medical device problem code 2017- above rated burst pressure.The device was not returned for analysis.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 identified no similar incidents from this lot.It was reported that the stent delivery system (sds) was deployed at 18 atmospheres (atm).It should be noted that the xience skypoint instructions for use (ifu) specifies the rated burst pressure (rbp) is 16 atm.It is unknown if the ifu deviation contributed to the reported event.The reported patient effects of pericardial effusion and perforation of vessels are listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported difficult stent activation.Additionally, a conclusive cause for the reported patient effect(s), and their relationship to the product, if any, cannot be determined; however, the subsequent 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.

• 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: 15117055
• Report Number: 2024168-2022-08257
• Device Sequence Number: 5766425
• Product Code: NIQ
• UDI-Device Identifier: 08717648233524
• UDI-Public: 08717648233524
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 08/19/2022

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: 09/19/2023
• Device Model Number: 1804400-38
• Device Catalogue Number: 1804400-38
• Device Lot Number: 1091541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2022
• Supplement Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2021
• 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: BMW GUIDE WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 86 KG