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

Model Number	1145300-38
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Activation Failure (3270)
Health Effect - Clinical Codes	Embolism (1829); Foreign Body In Patient (2687)
Date of Event	02/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported the procedure was to treat a lesion in the right coronary artery (rca).Two stents were successfully deployed without issues.A 3.0x38mm otw xience alpine stent delivery system (sds) was advanced to the lesion.An attempt was made to inflate the balloon however a hissing sound was heard and the balloon did not inflate.It was unknown if the hissing was coming from the hub of the sds or the non-abbott indeflator therefore the decision was made to remove the sds however during removal the stent dislodged and embolized to the rca.No intervention was performed and the stent remains in the rca.There was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported stent dislodgment was confirmed.The reported activation failure could not be confirmed due to the condition the device was 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.The investigation was unable to determine a conclusive cause for the reported activation failure.During removal from the anatomy the stent likely interacted with the anatomy and/or tortuosity of the patient causing the reported stent dislodgement and subsequent embolism and foreign body in patient.The reported patient effects of thrombosis and cardiac arrest are listed in the xience alpine everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE ALPINE
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9777160
• Report Number: 2024168-2020-01923
• Device Sequence Number: 16716510
• Product Code: NIQ
• UDI-Device Identifier: 08717648200113
• UDI-Public: 08717648200113
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 03/26/2020

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: 05/15/2020
• Device Model Number: 1145300-38
• Device Catalogue Number: 1145300-38
• Device Lot Number: 7051041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 03/26/2020
• 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: 2 DEPLOYED STENTS; ENCORE INDEFLATOR
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Weight: 112