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

Model Number	1550350-28
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned to abbott vascular 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 similar incidents and/or complaints reported from this lot.The investigation was unable to determine a conclusive cause for the reported packaging damage and sterility issue.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that during unpacking of a 3.50x28mm xience sierra, the foil pouch was noted without any damages, however, the inside clear tyvek pouch was noted with a hole in it.There were no damages noted to the chipboard box.The device was not used and there was no patient involvement.Another device was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: XIENCE SIERRA
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10489198
• Report Number: 2024168-2020-07363
• Device Sequence Number: 2889083
• Product Code: NIQ
• UDI-Device Identifier: 08717648227448
• UDI-Public: 08717648227448
• Combination Product (Y/N): Y
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/03/2020

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: 12/15/2021
• Device Model Number: 1550350-28
• Device Catalogue Number: 1550350-28
• Device Lot Number: 0060242
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1