MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number	1074225-28
Health Effect - Clinical Codes	Angina (1710); Stenosis (2263)
Date of Event	04/11/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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.Angina and stenosis are listed in the xience xpedition everolimus eluting coronary stent systems instructions for use, as known patient effects of coronary stenting procedures.Based on the case information and related record review, a conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined and there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that on (b)(6) 2014, after pre-dilatation, a 2.25x28 mm and 2.75x8 mm xience xpedition stent was implanted in mid and proximal left anterior descending coronary artery (lad).On (b)(6) 2016, the patient experienced acute coronary syndrome.Restenosis was found in the 2.25x28 mm xience xpedition stent and a non-target lesion.Percutaneous coronary intervention (pci) with a drug eluting stent was performed in the stent and balloon angioplasty was performed in the non-target lesion.The patient recovered on (b)(6) 2016.No additional information was provided.

• Brand Name: XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6574188
• Report Number: 2024168-2017-04233
• Device Sequence Number: 18989682
• Product Code: NIQ
• UDI-Device Identifier: 08717648162060
• UDI-Public: (01)08717648162060(17)160615(10)4061141
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/17/2017

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: 06/15/2016
• Device Catalogue Number: 1074225-28
• Device Lot Number: 4061141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2017
• Initial Report FDA Received Date: 05/17/2017
• 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: STENT: 2.75X8 MM XIENCE XPEDITION
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 49