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

Model Number	1550350-38
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the 90% stenosed, heavily tortuous and heavily calcified lesion causing the reported failure to advance.During removal the device interacted with the crushed and deformed distal tip of the guide liner causing the reported difficulty to remove and subsequent stent dislodgement.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was performed to treat a 90% stenosed, heavily tortuous, and heavily calcified lesion in the distal right coronary artery (rca).A 3.5x38 mm xience sierra stent delivery system (sds) failed to cross due to resistance with the anatomy.The sds was being removed but resistance with the guide liner was felt.The sds was removed and it was noted that the stent had dislodged.The guide liner was also removed and it was noted that the entire distal tip was crushed and deformed, potentially contributing to the resistance during removal and subsequent stent dislodgment.The stent remained on the guide wire near the proximal rca.The proximal rca was also planned to be stented; therefore, multiple nc trek balloon catheters (gradually upsizing) were used to appropriately expand the stent and deploy it at the intended location in the proximal rca.The procedure was successfully completed with the deployment of five xience sierra stents in the rca with no residual stenosis.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12055131
• Report Number: 2024168-2021-05375
• Device Sequence Number: 3503232
• Product Code: NIQ
• UDI-Device Identifier: 08717648227462
• UDI-Public: 08717648227462
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/23/2021

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: 08/15/2022
• Device Model Number: 1550350-38
• Device Catalogue Number: 1550350-38
• Device Lot Number: 1020941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 06/23/2021
• 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