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

Catalog Number	1550275-23
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	06/13/2018
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 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 similar incidents from this lot.The reported patient effects of dissection are listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effects of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported difficulty to deploy.Additionally, the investigation determined the reported deflation issues and difficulty to remove appear to be related to circumstances of the procedure as it is likely the balloon interacted with the deployed stent causing the reported deflation issues and difficulty to remove with the patient effect of intimal dissection.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported the procedure was to treat a tortuous and calcified lesion in the obtuse marginal (om) to left circumflex (lx).The 2.75x23mm rx xience sierra stent delivery system (sds) was advanced to the lesion with no resistance noted.The stent was deployed at 15 atmospheres (atm) for 15 seconds.Deflation was attempted however the balloon did not fully deflate as it was caught on the middle portion of the stent that was not fully apposed to the vessel wall.Resistance was met during retraction as the balloon was caught on the stent, resulting in the guide deep seating and causing a dissection.The sierra balloon was finally deflated and removed with no issue.Post dilatation was performed with a nc balloon, fully apposing the stent.Two additional sierra stents were deployed to treat the dissection.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.

• Brand Name: XIENCE SIERRA 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: 7630676
• Report Number: 2024168-2018-04859
• Device Sequence Number: 2412943
• Product Code: NIQ
• UDI-Device Identifier: 08717648227196
• UDI-Public: 08717648227196
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/22/2018

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: 04/26/2019
• Device Catalogue Number: 1550275-23
• Device Lot Number: 8041341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2018
• Initial Report FDA Received Date: 06/22/2018
• 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: Required Intervention