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

Model Number	1804275-33
Medical Device Problem Codes	Peeled/Delaminated (1454); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that after unpacking, unspecified foreign material was noted on the tip of a 2.75x33mm xience skypoint stent delivery system (sds).The device was not used and there was no patient involvement.An unspecified xience stent was used to success fully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.The returned device analysis found that the foreign material is a manufacturing component.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device and the device was sent to the chemical lab (chem) for further analysis.The reported contamination/decontamination problem was not confirmed.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 was unable to determine a conclusive cause for the reported contamination; however, factors that may contribute to a contamination include, but are not limited to, manufacturing, during shipment, sheath/stylet removal, storage or unpackaging of the device.In addition, a chem analysis was performed on the returned device which noted a strand of opaque, polymer-like material which was located coming from the inside lumen of the tip.It was concluded that the strand of opaque, polymer-like material from the lumen of the tip was not identified but resembled types of polyethylene.In this case, it is possible the strand of opaque, polymer-like material found in the lumen of the tip (polyethylene) may have occurred during sheath/stylet removal or during preparation of the device prior to use causing the reported contamination; however, this cannot be confirmed.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: 12952606
• Report Number: 2024168-2021-11173
• Device Sequence Number: 4443376
• Product Code: NIQ
• UDI-Device Identifier: 08717648233197
• UDI-Public: 08717648233197
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2021

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: 09/22/2023
• Device Model Number: 1804275-33
• Device Catalogue Number: 1804275-33
• Device Lot Number: 0091541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2021
• Supplement Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2020
• 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