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

Model Number	1804300-15
Medical Device Problem Codes	Inflation Problem (1310); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the mid right coronary artery lesion was pre-dilated with a 3.0x12 trek balloon catheter.A 3.0x15 mm xience skypoint stent delivery system (sds) was advanced to the target lesion, however the balloon failed to inflate, and the stent did not deploy.The sds was removed without issue.There were no adverse patient effects and no clinically significant delay in the procedure.A new same size skypoint sds was used to complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported inflation problem and activation failure could not be confirmed due to the condition the device was received 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.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely handling and/or manipulation of the device during advancement to the lesion caused the noted inner member/delivery system damage and subsequent leak.The noted leak likely caused the reported difficulties of inflation problem and activation failure.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• 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: 15621743
• Report Number: 2024168-2022-10744
• Device Sequence Number: 6345852
• Product Code: NIQ
• UDI-Device Identifier: 08717648233234
• UDI-Public: 08717648233234
• Combination Product (Y/N): Y
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2022

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: 03/31/2024
• Device Model Number: 1804300-15
• Device Catalogue Number: 1804300-15
• Device Lot Number: 2032341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2022
• Supplement Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2022
• 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: GUIDE CATHETER:JR4; GUIDE WIRE: RUNTHROUGH
• Patient Age: 62 YR
• Patient Sex: Male