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

Model Number	1074250-38
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	02/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of stenosis is listed in the xience xpedition, everolimus eluting coronary stent systems instructions for use, as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.The 2.25x28mm xience xpeidition stent referenced is filed under separate medwatch report number.
Event or Problem Description
(b)(6).It was reported that on (b)(6) 2014, the patient underwent a coronary procedure, treating a chronic total occlusion in the right coronary artery (rca).Three xience xpedition stents (2.25 x 28 mm, 2.5 x 38 mm, 3.0 x 18mm) were implanted.On (b)(6) 2019, 100% restenosis was noted in the 2.5 x 38 mm xience xpedition stent in the mid rca.On (b)(6) 2019, 100% restenosis was noted in the 2.25 x 28 mm xience xpedition stent in the distal rca.Balloon angioplasty was performed on (b)(6) 2019 in the mid and distal rca.The patient condition resolved on (b)(6) 2019.No additional information was provided.

• Brand Name: XIENCE XPEDITION
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9613487
• Report Number: 2024168-2020-00818
• Device Sequence Number: 10909053
• Product Code: NIQ
• UDI-Device Identifier: 08717648162183
• UDI-Public: 08717648162183
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/21/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2016
• Device Model Number: 1074250-38
• Device Catalogue Number: 1074250-38
• Device Lot Number: 4061841
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 58