MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE DRUG ELUTING SCAFFOLD

Catalog Number	1235300-23
Health Effect - Clinical Codes	Angina (1710); Thrombosis (2100)
Date of Event	01/09/2017
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.There was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.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.The reported patient effects of angina and thrombosis, as listed in the absorb gt1 instructions for use, are known adverse events associated with the use of a coronary scaffold in native coronary arteries.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
Event or Problem Description
It was reported that the initial procedure on (b)(6) 2017 was to treat a lesion located in the moderately calcified circumflex.A cutting balloon was advanced; however, would not cross.A 2.5 x 20 nc trek balloon catheter was advanced for pre-dilatation and the cutting balloon was readvanced successfully.The 3.0 x 23 mm absorb gt1 scaffold was deployed in the lesion and was post-dilated with a 3.0 x 20 mm nc trek at 16-18 atmospheres.Intravascular ultrasound confirmed the scaffold was fully apposed to the vessel wall and the lesion was confirmed to be less than 10% residual stenosis.Patient was placed on brilinta and aspirin.On (b)(6) 2017 the patient returned to the hospital experiencing chest pain and was rehospitalized.Angiography revealed thrombus at the distal end of the scaffold.A 2.0 x 20 mm trek balloon was used for pre-dilatation of the distal end of the scaffold followed by the deployment of a 2.75 x 12 mm multi-link vision stent.Post-dilatation was performed with a 3.0 x 12 mm trek balloon and the final outcome was good.No additional information was provided.

• Brand Name: ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Common Device Name: BIORESORBABLE DRUG ELUTING SCAFFOLD
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6265411
• Report Number: 2024168-2017-00576
• Device Sequence Number: 763196
• Product Code: PNY
• UDI-Device Identifier: 08717648213052
• UDI-Public: (01)08717648213052(17)170814(10)6081561
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P150023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/19/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/14/2017
• Device Catalogue Number: 1235300-23
• Device Lot Number: 6081561
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2017
• Initial Report FDA Received Date: 01/19/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 140