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

Catalog Number	1550275-38
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.A4: patient weight - 77.5k.
Event or Problem Description
It was reported that the procedure was performed to treat a mildly tortuous, mid right coronary artery.The 2.75x38mm rx xience sierra stent delivery system (sds) was advanced to the target lesion without resistance.The balloon ruptured at 10 atmospheres.The stent slightly expanded and it dislodged from the balloon.It was attempted to pull the sds in to an unspecified guiding catheter (gc) but was unsuccessful due to the partially inflated proximal end of the balloon.The sds and the gc were removed as a single unit.The stent was snared via the groin.The stent was stretched during removal.The delivery system was cut intentionally after it was removed from the anatomy to remove from the gc.The target lesion was left untreated but will be stented in the next couple of weeks; the exact date was not reported.There was no adverse patient sequela reported.No additional information was provided.
Additional Manufacturer Narrative
Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was returned for analysis.The reported stent dislodgement was confirmed.The reported material deformation could not be confirmed as the stent was not returned for analysis.The reported material rupture and difficulty to remove could not be confirmed due to the condition the device was received 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 was unable to determine a conclusive cause for the reported material rupture.The remaining difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE SIERRA
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8956497
• Report Number: 2024168-2019-11378
• Device Sequence Number: 19343220
• Product Code: NIQ
• UDI-Device Identifier: 08717648227226
• UDI-Public: 08717648227226
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2019

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: 01/23/2020
• Device Catalogue Number: 1550275-38
• Device Lot Number: 9011741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 10/19/2019
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 11/11/2019
• 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
• Patient Age: 56 YR
• Patient Weight: 78