MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number	1070275-48
Health Effect - Clinical Codes	Intimal Dissection (1333); Cardiac Arrest (1762); Death (1802); Thrombosis (2100)
Date of Event	08/21/2017
Type of Reportable Event	Death
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.The reported patient effects of dissection, death and thrombosis are listed in xience xpedition everolimus eluting coronary stent systems, instructions for use as known patient effects of coronary stenting procedures.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.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 xience xpedition 48 is currently not commercially available in the u.S.However, it is similar to a device sold in the us.
Event or Problem Description
It was reported that the procedure was to treat a mildly tortuous and mildly calcified de novo lesion in the proximal right coronary artery.Following pre-dilatation, a 2.75x48mm xience xpedition stent was deployed at 16 atmospheres.A dissection was noticed during the final cine review.A 2.5x15mm non-abbott stent was implanted to cover the dissection; however, acute stent thrombosis occurred.Subsequently the patient went into cardiac arrest.Thrombolytic, cardiopulmonary resuscitation, and cardio version were used in an attempt to save the patient; however, the efforts failed and the patient expired.No additional information was provided.

• Brand Name: XIENCE XPEDITION 48 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: 6839645
• Report Number: 2024168-2017-07258
• Device Sequence Number: 11117665
• Product Code: NIQ
• UDI-Device Identifier: 08717648199363
• UDI-Public: 08717648199363
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/01/2017

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: 07/03/2020
• Device Catalogue Number: 1070275-48
• Device Lot Number: 7062641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2017
• Initial Report FDA Received Date: 09/01/2017
• 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: Death